The Preserving Kidney Function in Children With CKD (PRESERVE) Study: Rationale, Design, and Methods.

Rationale & Objective: PRESERVE seeks to provide new knowledge to inform shared decision-making regarding blood pressure (BP) management for pediatric chronic kidney disease (CKD). PRESERVE will compare the effectiveness of alternative strategies for monitoring and treating hypertension on preserving kidney function; expand the National Patient-Centered Clinical Research Network (PCORnet) common data model by adding pediatric- and kidney-specific variables and linking electronic health record data to other kidney disease databases; and assess the lived experiences of patients related to BP management. Study Design: Multicenter retrospective cohort study (clinical outcomes) and cross-sectional study (patient-reported outcomes [PROs]). Setting & Participants: PRESERVE will include approximately 20,000 children between January 2009-December 2022 with mild-moderate CKD from 15 health care institutions that participate in 6 PCORnet Clinical Research Networks (PEDSnet, STAR, GPC, PaTH, CAPRiCORN, and OneFlorida+). The inclusion criteria were ≥1 nephrologist visit and ≥2 estimated glomerular filtration rate (eGFR) values in the range of 30 to <90 mL/min/1.73 m2 separated by ≥90 days without an intervening value ≥90 mL/min/1.73 m2 and no prior dialysis or kidney transplant. Exposures: BP measurements (clinic-based and 24-hour ambulatory BP); urine protein; and antihypertensive treatment by therapeutic class. Outcomes: The primary outcome is a composite event of a 50% reduction in eGFR, eGFR of <15 mL/min/1.73 m2, long-term dialysis or kidney transplant. Secondary outcomes include change in eGFR, adverse events, and PROs. Analytical Approach: Longitudinal models for dichotomous (proportional hazards or accelerated failure time) and continuous (generalized linear mixed models) clinical outcomes; multivariable linear regression for PROs. We will evaluate heterogeneity of treatment effect by CKD etiology and degree of proteinuria and will examine variation in hypertension management and outcomes based on socio-demographics. Limitations: Causal inference limited by observational analyses. Conclusions: PRESERVE will leverage the PCORnet infrastructure to conduct large-scale observational studies that address BP management knowledge gaps for pediatric CKD, focusing on outcomes that are meaningful to patients. Plain-Language Summary: Hypertension is a major modifiable contributor to loss of kidney function in chronic kidney disease (CKD). The purpose of PRESERVE is to provide evidence to inform shared decision-making regarding blood pressure management for children with CKD. PRESERVE is a consortium of 16 health care institutions in PCORnet, the National Patient-Centered Clinical Research Network, and includes electronic health record data for >19,000 children with CKD. PRESERVE will (1) expand the PCORnet infrastructure for research in pediatric CKD by adding kidney-specific variables and linking electronic health record data to other kidney disease databases; (2) compare the effectiveness of alternative strategies for monitoring and treating hypertension on preserving kidney function; and (3) assess the lived experiences of patients and caregivers related to blood pressure management.

Psychosocial supports within pediatric nephrology practices: A pediatric nephrology research consortium survey.

BACKGROUND: The landscape of available psychosocial services within pediatric nephrology care is poorly characterized. However, the effects of kidney disease on emotional health and health-related quality of life are well documented, as is the impact of social determinants of health on kidney disease outcomes. The objectives of this study were to assess pediatric nephrologists' perceptions of available psychosocial services and to elucidate inequities in access to psychosocial care. METHODS: A web-based survey was distributed to members of the Pediatric Nephrology Research Consortium (PNRC). Quantitative analyses were performed. RESULTS: We received responses from 49 of the 90 PNRC centers. With regards to dedicated services, social work was most commonly available (45.5-100%), followed by pediatric psychology (0-57.1%) and neuropsychology (0-14.3%), with no centers having embedded psychiatry. Availability of psychosocial providers was positively associated with nephrology division size, such that as center size increased, access to various psychosocial providers increased. Notably, the majority of respondents indicated that perceived need for psychosocial support exceeds that which is currently available, even at centers with higher levels of current support. CONCLUSIONS: Within the US, there is wide variability in the availability of psychosocial services within pediatric nephrology centers despite a well-documented necessity for the provision of holistic care. Much work remains to better understand the variation in funding for psychosocial services and in utilization of psychosocial professionals in the pediatric nephrology clinic, and to inform key best practices for addressing the psychosocial needs of patients with kidney disease.

Patient-Reported Outcomes Over 24 Months in Pediatric CKD: Findings From the MyKidneyHealth Cohort Study.

RATIONALE & OBJECTIVE: The lived experience of children with chronic kidney disease (CKD) is poorly characterized. We examined the associations between patient-reported outcome (PRO) scores measuring their fatigue, sleep health, psychological distress, family relationships, and global health with clinical outcomes over time in children, adolescents, and younger adults with CKD and investigated how the PRO scores of this group compare with those of other children, adolescents, and younger adults. STUDY DESIGN: Prospective cohort study. SETTING & PARTICIPANTS: 212 children, adolescentss, and adults aged 8 to 21 years with CKD and their parents recruited from 16 nephrology programs across North America. PREDICTORS: CKD stage, disease etiology, and sociodemographic and clinical variables. OUTCOME: PRO scores over 2 years. ANALYTICAL APPROACH: We compared PRO scores in the CKD sample with a nationally representative general pediatric population (ages 8 to 17 years). Change of PROs over time and association of sociodemographic and clinical variables with PROs were assessed using multivariable regression models. RESULTS: For all time points, 84% of the parents and 77% of the children, adolescents, and younger adults completed PRO surveys . The baseline PRO scores for the participants with CKD revealed a higher burden of fatigue, sleep-related impairment, psychological distress, impaired global health, and poorer family relationships compared with the general pediatric population, with median score differences≥1 SD for fatigue and global health. The baseline PRO scores did not differ by CKD stage or glomerular versus nonglomerular etiology. Over 2 years, PROs were stable with a<1-point annual change on average on each measure and intraclass correlation coefficients ranging from 0.53 to 0.79, indicating high stability. Hospitalization and parent-reported sleep problems were associated with worse fatigue, psychological health, and global health scores (all P<0.04). LIMITATIONS: We were unable to assess responsiveness to change with dialysis or transplant. CONCLUSIONS: Children with CKD experience a high yet stable burden of impairment across numerous PRO measures, especially fatigue and global health, independent of disease severity. These findings underscore the importance of assessing PROs, including fatigue and sleep measures, in this vulnerable population. PLAIN-LANGUAGE SUMMARY: Children with chronic kidney disease (CKD) have many treatment demands and experience many systemic effects. How CKD impacts the daily life of a child is poorly understood. We surveyed 212 children, adolescents, and younger adults with CKD and their parents over 24 months to assess the participants' well-being over time. Among children, adolescents, and younger adults with CKD we found a very high and persistent burden of psychological distress that did not differ by degree of CKD or type of kidney disease. The participants with CKD endorsed greater impairment in fatigue and global health compared with healthy children, adolescents, and younger adults, and parent-reported sleep problems were associated with poorer patient-reported outcome (PRO) scores across all domains. These findings emphasize the importance of including PRO measures, including fatigue and sleep measures, into routine clinical care to optimize the lived experience of children with CKD.

Food insecurity during COVID-19 in children with end-stage kidney disease: a pilot study.

BACKGROUND: Food insecurity, an important social determinant of health among children, has become more common during the COVID-19 pandemic. Children with chronic diseases including end-stage kidney disease (ESKD) are at higher risk of food insecurity due to their complex care needs, medication burden, and dietary restrictions. No data exists describing food insecurity prevalence in pediatric ESKD patients during the COVID-19 pandemic. METHODS: Food insecurity was assessed among families of children (age 0-18 years) with ESKD on chronic dialysis at two pediatric academic medical centers. Families were screened in April 2020 using the Hunger Vital Sign, a validated 2-question screening tool. We assessed impact of COVID-19 on food insecurity. We compared serum phosphorus "pre-COVID" (January/February 2020) to "during COVID" (April/May 2020). RESULTS: A total of 29 families enrolled in this study. 62% (18/29) of children with ESKD lived in food insecure households, and of those, 72% (13/18) reported that COVID-19 had worsened their food insecurity status. During the COVID-19 pandemic, food insecure patients experienced greater rise in their serum phosphorus levels (1.1 mg/dL vs. 0 mg/dL, p = 0.03) and decreased likelihood of having adequate phosphorus control (50% vs. 11%, p = 0.03). CONCLUSION: Food insecurity was common among children with ESKD on chronic dialysis during the COVID-19 pandemic. Children with food insecurity had a greater increase in their phosphorus levels during the pandemic than did food secure children. Further exploration into how food resources such as an onsite food pantry impacts food insecurity and phosphorus control in children with ESKD is essential.

Association Between Continuous Kidney Replacement Therapy Clearance and Outcome in Pediatric Patients With Hyperammonemia Not Due to Inborn Error of Metabolism.

OBJECTIVES: To describe a single-center experience of pediatric patients with hyperammonemia not due to inborn errors of metabolism and determine the association between use of continuous kidney replacement therapy (CKRT) treatment and outcomes. DESIGN: Retrospective cohort study. SETTING: Tertiary-care children's hospital. PATIENTS: All children less than 21 years old admitted to the hospital with hyperammonemia defined as an elevated ammonia levels (>100 µmol/L) not due to inborn error of metabolism. INTERVENTIONS: None. MEASURES AND MAIN RESULTS: Of 135 children with hyperammonemia, the most common reason for admission was infection in 57 of 135 (42%), congenital heart disease in 20 of 135 (14%), and bone marrow transplantation in 10 of 135 (7%). The overall mortality was 61% (82 of 135), which increased with degree of hyperammonemia (17 of 23 [74%] in those with ammonia >250 µmol/L). After multivariable regression, hyperammonemia severity was not associated with mortality (aOR, 1.4; 95% CI, 0.92-2.1; p = 0.11). Of the 43 patients (32%) receiving CKRT, 21 were prescribed standard clearance and 22 high clearance. The most common indications for CKRT were fluid overload in 17 of 43 (42%) and acute kidney injury or uremia in 16 of 43 (37%). Mean CKRT duration was 13 days. There was no difference between standard and high clearance groups in risk of death (76% vs 86%; p = 0.39), cerebral edema on CT scan (19% vs 27%; p = 0.52), nor decrease in ammonia levels after 24 or 48 hours of CKRT ( p = 0.20, p = 0.94). Among those receiving CKRT, we failed to find an association between high clearance and decreased risk of death in multivariable analysis (aOR, 1.2; 95% CI, 0.64-2.3; p = 0.55). CONCLUSIONS: In our single-center retrospective study, we failed to find an association between clearance on CKRT and improved survival nor decreased cerebral edema on head imaging. In fact, we failed to find an association between ammonia level and mortality, after controlling for illness severity.

Food Insecurity During COVID-19 in Children with End-Stage Kidney Disease: A Pilot Study.

Background Food insecurity, an important social determinant of health among children, has become more common during the COVID-19 pandemic. Children with chronic diseases including end-stage kidney disease (ESKD) are at higher risk of food insecurity due to their complex care needs, medication burden, and dietary restrictions. No data exists describing food insecurity prevalence in pediatric ESKD patients during the COVID-19 pandemic. Methods Food insecurity was assessed among families of children (age 0-18 years) with ESKD on chronic dialysis at two pediatric academic medical centers. Families were screened in April 2020 using the Hunger Vital Sign, a validated 2-question screening tool. We assessed impact of COVID-19 on food insecurity. We compared serum phosphorus "pre-COVID" (January/February 2020) to "during COVID" (April/May 2020). Results A total of 29 families enrolled in this study. 62% (18/29) of children with ESKD lived in food insecure households, and of those, 72% (13/18) reported that COVID-19 had worsened their food insecurity status. During the COVID-19 pandemic, food insecure patients experienced greater rise in their serum phosphorus levels ( p =0.03) and decreased likelihood of having adequate phosphorus control ( p =0.03). Conclusion Food insecurity was common among children with ESKD on chronic dialysis during the COVID-19 pandemic. Children with food insecurity had a greater increase in their phosphorus levels during the pandemic than did food secure children. Further exploration into how food resources such as an onsite food pantry impacts food insecurity and phosphorus control in children with ESKD is essential.

Systemic Hypertension in Infants with Bronchopulmonary Dysplasia.

PURPOSE OF REVIEW: Neonatal hypertension is increasingly recognized as improvements in neonatal intensive care have led to increased survival of premature infants. Among infants with bronchopulmonary dysplasia (BPD), the rates of hypertension are much higher than the general neonatal population. However, the etiology and pathophysiology of this increased risk of hypertension in neonates with lung disease remain unclear. RECENT FINDINGS: Among infants with bronchopulmonary dysplasia, the rates of hypertension are much higher than the general neonatal population. New studies suggest outcomes in neonates with BPD with hypertension are usually good, with resolution of hypertension in most infants with lung disease. Several potential mechanisms of hypertension in this patient population have been recently proposed. This review focuses on the recent epidemiologic data on prevalence of hypertension in neonates with bronchopulmonary dysplasia, reviews the typical clinical course, and discusses available strategies for management of infants with bronchopulmonary dysplasia that develop hypertension.

Omentectomy reduces the need for peritoneal dialysis catheter revision in children: a study from the Pediatric Nephrology Research Consortium.

BACKGROUND: There are no multi-center studies examining omentectomy and peritoneal dialysis (PD) catheter revision in the pediatric dialysis population. METHODS: We performed a retrospective study at eight centers within the Pediatric Nephrology Research Consortium (PNRC). Data review included all incident tunneled PD catheters placed between 1/1/2011 and 12/31/2016 in pediatric stage 5 chronic kidney disease (CKD 5) patients. The primary outcome was the need for catheter revision and/or replacement. Multivariable logistic regression was performed to evaluate predictors for catheter revision/replacement. RESULTS: Data from 184 children (62.5% male; median age 7.4 years) were analyzed. Omentectomy was completed in 63.6% (n = 117). Revision/replacement occurred in 34.2% (n = 63); median time to revision/replacement was 38.5 days after insertion. PD catheter revision/replacement catheter occurred in 23.9% who underwent omentectomy versus 52.2% without omentectomy (p = 0.0005). Children ≥ 6 years at the time of catheter insertion experienced fewer revisions/replacements (18.2% age ≥ 6 vs. 56.5% age < 6 years, p <0.001). After adjusting for covariates, omentectomy reduced the need for revision by 63%; revision was 3.66 times more likely in those < 6 years of age. CONCLUSIONS: This multi-center study demonstrates that omentectomy at the time of PD catheter insertion in pediatric patients is strongly associated with reduced likelihood of PD catheter revision. Omentectomy should be considered at the time of PD catheter insertion, especially in young children who are at high risk for PD catheter malfunction. A higher resolution version of the Graphical abstract is available as Supplementary information.

Coronavirus disease 2019 (COVID-19) in two pediatric patients with kidney disease on chronic immunosuppression: A case series.

Coronavirus disease 2019 (COVID-19) is a highly infectious disease caused by the severe acute respiratory syndrome coronavirus 2 virus (SARS-CoV-2). While children appear to experience less severe disease than adults, those with underlying conditions such as kidney disease may be more susceptible to infection. Limited data are present for children with kidney disease, and there are limited prior reports of pediatric hemodialysis patients with COVID-19. This report describes the mild clinical disease course of COVID-19 in two pediatric patients with chronic kidney disease, one on hemodialysis and both on chronic immunosuppression. We review treatment in these patients, as well as our measures to reduce transmission among our hemodialysis patients and staff.

Assessment of Seroconversion to SARS-CoV-2 in a Cohort of Pediatric Kidney Transplant Recipients.

Background: The occurrence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the associated coronavirus disease 2019 (COVID-19) have profoundly affected adult kidney disease patients. In contrast, pediatric solid organ transplant recipients, including pediatric kidney transplant (KT) recipients, do not seem to be at particularly higher risk for SARS-CoV-2 infection or for severe COVID-19 disease. This patient population might be protected by certain mechanisms, such as the immunosuppressive medications with their anti-inflammatory properties or simply being well-versed in self-protection techniques. Assessing SARS-CoV-2 antibody serologies could potentially help understand why this patient population is apparently spared from severe SARS-CoV-2 clinical courses. Objective: To examine SARS-CoV-2 serologic status in a cohort of pediatric KT recipients. Methods: SARS-CoV-2 anti-spike IgG and IgM antibodies were measured by three different methods in pediatric KT recipients coming for routine clinic visits immediately post-confinement in May-June of 2020. The patients were considered seroconverted if SARS-CoV-2 antibodies were positive by 2/3 methods and weak positive/indeterminate if positive by 1/3. Results: Thirty-one patients were evaluated (about 1/3 of our institution's pediatric KT population). One patient seroconverted, while three were considered weak positive/indeterminate. None were symptomatic and none had nasopharyngeal PCR confirmed SARS-CoV-2 disease. Conclusions: Seroconversion to SARS-CoV-2 was rare in this population and likely reflects the social distancing practiced by these patients. The results will serve as a foundation for a future longitudinal study to evaluate the long-term emergence and persistence of antibodies in this population and may inform studies of response to a future vaccine.

The Improving Renal Outcomes Collaborative: Blood Pressure Measurement in Transplant Recipients.

BACKGROUND AND OBJECTIVES: Hypertension is highly prevalent in pediatric kidney transplant recipients and contributes to cardiovascular death and graft loss. Improper blood pressure (BP) measurement limits the ability to control hypertension in this population. Here, we report multicenter efforts from the Improving Renal Outcomes Collaborative (IROC) to standardize and improve appropriate BP measurement in transplant patients. METHODS: Seventeen centers participated in structured quality improvement activities facilitated by IROC, including formal training in quality improvement methods. The primary outcome measure was the proportion of transplant clinic visits with appropriate BP measurement according to published guidelines. Prospective data were analyzed over a 12-week pre-intervention period and a 20-week active intervention period for each center and then aggregated as of the program-specific start date. We used control charts to quantify improvements across IROC centers. We applied thematic analysis to identify patterns and common themes of successful interventions. RESULTS: We analyzed data from 5392 clinic visits. At baseline, BP was measured and documented appropriately at 11% of visits. Center-specific interventions for improving BP measurement included educating clinic staff, assigning specific team member roles, and creating BP tracking tools and alerts. Appropriate BP measurement improved throughout the 20-week active intervention period to 78% of visits. CONCLUSIONS: We standardized appropriate BP measurement across 17 pediatric transplant centers using the infrastructure of the IROC learning health system and substantially improved the rate of appropriate measurement over 20 weeks. Accurate BP assessment will allow further interventions to reduce complications of hypertension in pediatric kidney transplant recipients.

Adiposity, Sex, and Cardiovascular Disease Risk in Children With CKD: A Longitudinal Study of Youth Enrolled in the Chronic Kidney Disease in Children (CKiD) Study.

RATIONALE & OBJECTIVE: Traditional and nontraditional cardiovascular disease risk factors are highly prevalent in children with chronic kidney disease (CKD). We examined the longitudinal association of adiposity with cardiac damage among children with CKD and explored whether this association was modified by sex. STUDY DESIGN: Prospective cohort study. SETTING & PARTICIPANTS: Children with mild-to-moderate CKD enrolled in the Chronic Kidney Disease in Children (CKiD) Study at 49 pediatric nephrology centers across North America. EXPOSURE: Age- and sex-specific body mass index (BMI) z score. OUTCOME: Age- and sex-specific left ventricular mass index (LVMI) z score and left ventricular hypertrophy (LVH). ANALYTICAL APPROACH: Longitudinal analyses using mixed-effects models to estimate sex-specific associations of BMI z scores with LVMI z score and with LVH, accounting for repeated measurements over time. RESULTS: Among 725 children with 2,829 person-years of follow-up, median age was 11.0 years and median estimated glomerular filtration rate was 52.6mL/min/1.73m2. Nearly one-third of both boys and girls were overweight or obese, median LVMI z score was 0.18 (IQR: -0.67, 1.08), and 11% had LVH. Greater BMI z scores were independently associated with greater LVMI z scores and greater odds of LVH. For each 1-unit higher BMI z score, LVMI z score was 0.24 (95% CI, 0.17-0.31) higher in boys and 0.38 (95% CI, 0.29-0.47) higher in girls (Pinteraction = 0.01). For each 1-unit higher BMI z score, the odds of LVH was 1.5-fold (95% CI, 1.1-2.1) higher in boys and 3.1-fold (95% CI, 1.8-4.4) higher in girls (Pinteraction = 0.005). LIMITATIONS: Not all children had repeated measurements. LVH is a surrogate and not a hard cardiac outcome. The observational design limits causal inference. CONCLUSIONS: In children, adiposity is independently associated with the markers of cardiac damage, LVMI z score and LVH. This association is stronger among girls than boys. Pediatric overweight and obesity may therefore have a substantial impact on cardiovascular risk among children with CKD.

Blood pressure in children with chronic kidney disease: lessons learned from the Chronic Kidney Disease in Children Cohort Study.

Cardiovascular disease (CVD) is common among children and adolescents with chronic kidney disease (CKD) and end-stage kidney disease (ESRD). However, the early accrual of CVD risk factors in children with CKD has not been well studied. The Chronic Kidney Disease in Children (CKiD) Study, a multicenter, prospective cohort study of children with mild-to-moderate CKD at study entry counts among its primary aims investigation of the drivers of CVD risk in this population. As the most prevalent CVD risk factor in children with CKD, blood pressure (BP) has been a major focus of investigation for the CKiD Study Group. Over the first 15 years of the study, landmark publications have better defined the prevalence of hypertension, the frequency with which it is under-recognized and thus undertreated, and the consequences of elevated BP in this cohort. The purpose of this review is to summarize the contributions made by the CKiD Study in advancing knowledge of BP in this high-risk population, and to highlight areas in need of further study.

Pharmacologic Management of Pediatric Hypertension.

Hypertension in children is common, and the prevalence of primary hypertension is increasing with the obesity epidemic and changing dietary choices. Careful measurement of blood pressure is important to correctly diagnose hypertension, as many factors can lead to inaccurate blood pressure measurement. Hypertension is diagnosed based on comparison of age-, sex-, and height-based norms with the average systolic and diastolic blood pressures on three separate occasions. In the absence of hypertensive target organ damage (TOD), stage I hypertension is managed first by diet and exercise, with the addition of drug therapy if this fails. First-line treatment of stage I hypertension with TOD and stage II hypertension includes both lifestyle changes and medications. First-line agents include angiotensin-converting enzyme (ACE) inhibitors, thiazide diuretics, and calcium-channel blockers. Hypertensive emergency with end-organ effects requires immediate modest blood pressure reduction to alleviate symptoms. This is usually accomplished with IV medications. Long-term reduction in blood pressure to normal levels is accomplished gradually. Specific medication choice for outpatient hypertension management is determined by the underlying cause of hypertension and the comparative adverse effect profiles, along with practical considerations such as cost and frequency of administration. Antihypertensive medication is initiated at a starting dose and can be gradually increased to effect. If ineffective at the recommended maximum dose, an additional medication with a complementary mechanism of action can be added.

Late-Occurring Vancomycin-Associated Acute Kidney Injury in Children Receiving Prolonged Therapy.

BACKGROUND: Acute kidney injury (AKI) in patients receiving vancomycin has been associated with trough concentrations ≥15 mg/L and longer therapy duration. The objective of this study was to determine the incidence and factors associated with late AKI in children receiving ≥8 days of vancomycin therapy. METHODS: Children aged 30 days to 17 years who were admitted to our institution and received intravenous vancomycin for at least 8 days during January to December of 2007 and 2010 and had a suspected or proven gram-positive infection were included. Late AKI was categorized as AKI occurring after the first 7 days of therapy and within 48 hours following vancomycin discontinuation. The primary outcome was incidence of late AKI as determined by modified pRIFLE criteria. RESULTS: One-hundred sixty-seven patients were included, with a median (interquartile range) age (years) and weight (kg) of 2 (1-7) and 12.5 (8.9-23.8). Late AKI was identified in 12.6% (21/167). A higher percentage of late AKI patients received concomitant treatment with intravenous acyclovir, amphotericin products, or piperacillin-tazobactam. Age <1 year was the only factor independently associated with late AKI development (odds ratio = 4.4; 95% confidence interval = 1.3-15.4). CONCLUSIONS: Late AKI occurred in nearly 13% of children receiving ≥8 days of vancomycin therapy. This study suggests that vancomycin trough concentrations are not associated with late AKI, but that age <1 year and concomitant administration of certain nephrotoxins may be factors associated with increased risk.

Cinacalcet administration by gastrostomy tube in a child receiving peritoneal dialysis.

A 2-year-old male with chronic kidney disease with secondary hyperparathyroidism developed hypercalcemia while receiving calcitriol, without achieving a serum parathyroid hormone concentration within the goal range. Cinacalcet 15 mg (1.2 mg/kg), crushed and administered via gastrostomy tube, was added to the patient's therapy. This therapy was effective in achieving targeted laboratory parameters in our patient despite instructions in the prescribing information that cinacalcet should always be taken whole.