The feasibility of Technology, Application, Self-Management for Kidney (TASK) intervention in post-kidney transplant recipients using a pre/posttest design.

BACKGROUND: Weight gain after a kidney transplant remains a major problem that can lead to adverse effects on morbidity and mortality. The posttransplant phase provides a window of opportunity to improve the engagement of self-management of care for lifestyle modifications for diet and physical activity. The purpose of our study was to (1) test the feasibility of recruitment, retention, and adherence for using the Technology, Application, Self-Management for Kidney (TASK) intervention in post-kidney transplant recipients (≥ 18 years of age) at baseline, 4, 8, and 12 weeks; and (2) estimate the preliminary effects of the TASK intervention in producing change over time for blood pressure (BP), weight, fruits/vegetable intake, fiber intake, sodium intake, self-efficacy to exercise, and perceived stress. METHODS: This study used a 12-week pre/posttest design using to test the feasibility of the TASK intervention. We applied paired t-tests and McNemar's test to compare the outcomes at weeks 4, 8, and 12. RESULTS: We met our recruitment goal (N = 20) and found a 15% attrition rate (n = 3) at Week 12. Adherence rate among the study completers for recording daily food intake was 83-94% over the 12 weeks and for recording daily physical activity was 17-33% over the 12 weeks. We observed improvements over time for BP, weight, fruits/vegetable intake, fiber intake, and sodium intake; these differences were non-significant, although clinically important. We did find a significant difference from baseline to 12 weeks in weight reduction (p = 0.02), self-efficacy to exercise (p = 0.003), and perceived stress (p = 0.04). CONCLUSIONS: The data suggest the TASK intervention was feasible for kidney recipients to use and resulted in weight control, increased self-efficacy to exercise, and decreased perceived stress. TRIAL REGISTRATION: ClinicalTrials.gov #:NCT05151445.

Genetic evaluation of living kidney donor candidates: A review and recommendations for best practices.

The growing accessibility and falling costs of genetic sequencing techniques has expanded the utilization of genetic testing in clinical practice. For living kidney donation, genetic evaluation has been increasingly used to identify genetic kidney disease in potential candidates, especially in those of younger ages. However, genetic testing on asymptomatic living kidney donors remains fraught with many challenges and uncertainties. Not all transplant practitioners are aware of the limitations of genetic testing, are comfortable with selecting testing methods, comprehending test results, or providing counsel, and many do not have access to a renal genetic counselor or a clinical geneticist. Although genetic testing can be a valuable tool in living kidney donor evaluation, its overall benefit in donor evaluation has not been demonstrated and it can also lead to confusion, inappropriate donor exclusion, or misleading reassurance. Until more published data become available, this practice resource should provide guidance for centers and transplant practitioners on the responsible use of genetic testing in the evaluation of living kidney donor candidates.

Kidney transplant from HCV viremic donors to HCV-negative recipients and risk for de novo donor specific antibodies and acute rejection.

BACKGROUND: Kidney transplantation from HCV-viremic donors into uninfected recipients is associated with excellent short-term outcomes. However, concerns regarding an increased risk for the development of de novo donor specific antibodies (DSA) and acute rejection have been raised in single center reports. METHODS: A retrospective study of HCV-negative kidney-only transplant recipients between 2018 and 2020. Patients were grouped based on the donor HCV status into group 1; HCV-viremic donors, and group 2; HCV-negative donors. Inverse probability of treatment weighting (IPTW), with weights derived from the propensity score, were used to estimate the effect of donors' HCV-viremia on the recipients. The primary objective was to compare the 1-year incidence of de novo DSA. Secondary outcomes included group comparison of the incidence of biopsy proven acute rejection (BPAR), 1-year patient and allograft survival, and 1-year renal allograft function. RESULTS: A total of 71 patients were included in the HCV NAT+ group, and 440 in the HCV- negative group. One-year incidence of de novo DSA was higher in the HCV NAT+ group in the IPTW weighted analysis (19% vs. 9%, p = .02). In the unweighted analysis, BPAR occurred in 7% of recipients in the HCV NAT+ group, compared to 3% in the control group (p = .06). However, due to the low event rate in the in the IPTW weighted groups, a statistical significance test could not be performed. Average estimated GFR was higher in the HCV-viremic group at 3 months (61 vs. 53 ml/min/1.73 m2 p = .002), but comparable at 6 (59 vs. 56 ml/min/1.73 m2 , p = .31) and 12 months (60 vs. 55 ml/min/1.73 m2 , p = .07). Patient and allograft survival were comparable between the two groups. CONCLUSION: Kidney transplant from HCV-viremic donors was associated with an increased risk for the development of post-transplant de novo DSA in the first year after transplantation, but no difference in patient and graft survival.

Kidney transplant from hepatitis C viremic donors into aviremic recipients and risk for post-transplant BK and cytomegalovirus infection.

BACKGROUND: kidney transplantation from Hepatitis C virus (HCV) viremic donors to uninfected recipients is associated with excellent short-term outcomes. However, HCV viremia might be associated with an increased risk for post-transplant viral complications. METHODS: We designed a retrospective study of HCV-negative kidney-only transplant recipients between 2018 and 2020. Recipients were grouped into group 1; HCV-negative donors, and group 2; HCV-viremic donors. Patients were matched 1:1 using propensity score. The primary objectives were to compare the incidence of cytomegalovirus (CMV) viremia ≥ 200 ml/IU, and BK viremia ≥1000 copies/ml between the groups. Secondary outcomes included group comparison of CMV disease, BK viremia ≥10 000 copies/ml, and 1-year patient and allograft survival. RESULTS: The study included 634 patients in group 1, and 71 patients in group 2. Sixty-five pairs of patients were matched. Incidence of CMV viremia (33.3% vs. 40.0%, p = .4675), and BK viremia (15.9% vs. 27.7%, p = .1353) did not differ significantly between groups in the matched cohort. Incidence of CMV disease (81.0% vs. 76.9%, p = 1.000), and BK viremia ≥10 000 copies/ml (9.5% vs. 16.9%, p = .2987) were comparable between groups. There was no difference in the 1-year patient or allograft survival between groups. CONCLUSION: kidney transplant from HCV-viremic donors is not associated with increased risk for BK or CMV viremia.

Lessons Learned for Training a Research Team and Teaching Kidney Transplant Recipients How to Use a Mobile Health Technology for Dietary Intake and Physical Activity via a Virtual Platform.

Kidney transplant centers and other health care organizations historically have struggled to merge lifestyle management for diet and physical activity into clinical practice. The use of mobile health (mHealth) applications has the potential for kidney transplant recipients to track calorie intake and physical activity in real time. Few studies have reported how they trained their research team and participants how to use mHealth technology in real time. The purpose of this study was to describe lessons learned for training a research team and teaching kidney transplant recipients how to use mHealth technology utilizing a virtual format. Findings suggest that time and educational materials, and using verbal, written, and visual information are critical when conducting a research study using a virtual format.

Maintenance phase of a physical activity intervention in older kidney transplant recipients: A 12-month follow-up.

Daily walking activities are associated with improving cardiovascular outcomes in older kidney transplant recipients. However, little is known regarding physical activity adherence outcomes in older kidney recipients. The purpose of this randomized controlled trial 12-month follow-up study was to evaluate the feasibility of the intervention (SystemCHANGE™ + activity tracker) during the maintenance period (7-12 months), compared to an attention-control group (activity tracker only) in older kidney recipients (age 60 and older). The sample included 60 participants (n = 30 IG; n = 30 ACG). Adherence rates for wearing the activity tracker daily were 96.5% in the IG and 80.8% in the ACG. The IG demonstrated within-group improvements for blood pressure at 12 months. Overall, there was a decrease in the average daily steps observed in both groups. These data suggest this intervention is feasible and additional boosters should be considered during the maintenance period to encourage physical activity.

A review of kidney transplantation from HCV-viremic donors into HCV-negative recipients.

The safety and efficacy of direct-acting antiviral therapies have allowed the transplantation of organs from hepatitis C virus (HCV)-viremic donors into uninfected recipients. This novel strategy contrasts with the previous standard-of-care practice of limiting the transplantation of HCV infected-donor organs to HCV-infected recipients, or all too often, discarding viable organs. In this review, we summarize the published literature about the safety and feasibility of transplanting organs from HCV-viremic donors, the challenges that hinder wider adoption of this strategy, and future research needs.

A real-world, single-center experience of the utilization of hepatitis C-viremic kidneys for hepatitis C-negative recipients.

The advent of direct-acting antiviral (DAA) therapies has allowed kidney transplantation from hepatitis C (HCV)-viremic donors into negative recipients. We evaluated the safety and feasibility of such practice when utilizing a patient's health plan to cover the cost for DAAs. MATERIALS AND METHODS: This was a prospective, non-randomized, pilot clinical study. 30 HCV-negative participants received kidney transplant from HCV-viremic deceased donors. HCV polymerase chain reaction (PCR) was checked on day 3 post transplant, and a request for pan-genotypic DAA therapy was sent once viremia was confirmed. Primary outcomes were the percentage of patients achieving sustained virologic response defined as undetectable HCV PCR 12 weeks after therapy completion, and the percentage of patients receiving DAAs via patient's health plan. RESULTS: HCV viremia occurred in all 30 recipients. Sustained viral response was achieved in 93% of the patients. Two patients failed first-line DAAs, 1 patient due to non-compliance with the prescribed regimen while the other due to NS5A mutation. DAA therapy was successfully obtained via patient's health plan in 28/30 patients. There was no significant liver-related complication, patient death, or graft loss. CONCLUSION: Kidney transplantation from HCV-viremic donors appears to be safe. However, challenges with obtaining DAA coverage in the United States persist.

Early Posttransplant Blood Transfusion and Risk for Worse Graft Outcomes.

INTRODUCTION: Blood transfusion is a risk factor for allosensitization. Nevertheless, blood transfusion posttransplant remains a common practice. We evaluated the effect of posttransplant blood transfusion on graft outcomes. METHODS: We included nonsensitized, first-time, kidney-alone recipients transplanted between 1 July 2015 and 31 December 2017. Patients were grouped based on receiving blood transfusion in the first 30 days posttransplant. The primary end point was a composite outcome of biopsy-proven acute rejection, death of any cause, or graft failure in the first year posttransplant. Secondary outcomes included the individual components of the primary outcome and the cumulative incidence of de novo donor-specific antibodies (DSAs). RESULTS: Two hundred seventy-three patients were included. One hundred twenty-seven (47%) received blood transfusion. Patients in the transfusion group were more likely to be older, have had a deceased donor, and have received induction with basiliximab. There was no difference between groups in the composite primary outcome (adjusted hazard ratio = [HR] 1.34; 95% confidence interval [CI], 0.83-2.17; P = 0.23). The cumulative incidence of de novo DSAs during the first year posttransplant was similar between groups (12.8% transfusion vs. 10.9% no transfusion, P = 0.48). CONCLUSION: Early transfusion of blood products in kidney transplant recipients receiving induction with lymphocyte depletion was not associated with an increased hazard of experiencing acute rejection, death from any cause, or graft loss.

Outcomes of hepatitis C virus seropositive donors to hepatitis C virus seronegative liver recipients: A large single center analysis.

INTRODUCTION AND OBJECTIVES: The success of direct-acting antivirals (DAA) has transformed the management of hepatitis C virus (HCV) infection and has led to the expansion of the deceased donor organ pool for liver transplantation. MATERIAL AND METHODS: We present a single center retrospective review of liver transplantations performed on HCV-seronegative recipients from HCV-seropositive organs from 11/2017 to 05/2020. HCV nucleic acid testing (NAT) was performed on HCV-seropositive donors to assess active HCV infection. RESULTS: 42 HCV-seronegative recipients underwent a liver transplant from a HCV-seropositive donor, including 21 NAT negative (20 liver, 1 simultaneous liver kidney transplant) and 21 NAT positive liver transplants. Two (9.5%) HCV antibody positive/NAT negative recipients developed HCV viremia and achieved sustained virologic response with DAA therapy. The remaining patients with available data (19 patients) remained polymerase chain reaction (PCR) negative at 6 months. 20 (95%) of HCV antibody positive/NAT positive recipients had a confirmed HCV viremia. 100% of patients with available data (15 patients) achieved SVR. Observed events include 1 mortality and graft loss and equivalent rates of post-transplant complications between NAT positive and NAT negative recipients. CONCLUSIONS: HCV-seropositive organs can be safely transplanted into HCV-seronegative patients with minimal complications post-transplant.

A Pilot Randomized Controlled Trial Using SystemCHANGE™ Approach to Increase Physical Activity in Older Kidney Transplant Recipients.

BACKGROUND: Cardiovascular disease is the leading cause of death in kidney transplant recipients. Physical activity after transplant is the most modifiable nonpharmacological factor for improving cardiovascular outcomes. Few studies have tested walking interventions to enhance daily steps and health outcomes in older kidney recipients. METHODS: Using a pilot feasibility randomized clinical trial design, we tested the feasibility and efficacy of a 6-month SystemCHANGE™ (Change Habits by Applying New Goals and Experience) + Activity Tracker intervention for recruitment, retention, daily steps, and health outcomes (blood pressure, heart rate, body mass index, waist circumference, and physical function). The SystemCHANGE™ + Activity Tracker intervention taught participants to use a multicomponent intervention that connects person-centered systems solutions combined with visual feedback from a mobile activity tracker to achieve daily step goals. RESULTS: Fifty-three participants (mean age 65 years, 66% male, and 57% white) participated with 27 in the intervention and 26 in the control group. The study protocol was feasible to deliver with high adherence to the protocol in both groups. The intervention group increased daily steps at 3 months (mean difference, 608; standard error = 283, P = .03) compared to the control group. The secondary outcome of heart rate decreased for the intervention group (baseline [mean] 74.4+ 10.8 [standard deviation, SD;] vs 6 months [mean] 67.6+ 11.3 [SD]; P = .002) compared to the control group (baseline [mean] 70.67+ 10.4 [SD]; vs 6 months [mean] 70.2 + 11.1 [SD]; P = .83). CONCLUSIONS: SystemCHANGE™ + Activity Tracker intervention appears to be feasible and efficacious for increasing daily steps in older kidney recipients.

Recruitment of Older Kidney Transplant Recipients to a Longitudinal Study.

BACKGROUND: Currently, limited information is available regarding selection of the most successful strategies for recruitment of older adult kidney transplant recipients as research participants. OBJECTIVE: The aim of this study was to explore multiple modes of recruitment strategies to enroll older kidney transplant recipients in a 1-year longitudinal study. METHODS: We used a feasibility design to explore the following recruitment methods: face-to-face contact in the transplant clinic, paper flyers placed in the transplant clinic, Facebook, an online transplant newsletter, and a university website listing of research studies. RESULTS: Enrollment was open for 9 months, during which time websites and the Facebook portal were active, 142 newsletters were e-mailed, and 424 patients were approached in the transplant clinic. Among patients approached in the clinic, 12 did not own a smartphone required for the study. The sample consisted of 60 participants (39 men, 21 women), with a mean age of 64.5 ± 4.7 years. Of the participants who enrolled in the study, the largest number (75%, n = 45) was recruited using the face-to-face method in the transplant clinic. The online transplant newsletter was the second-best recruitment source (18%, n = 11). DISCUSSION: Recruitment strategies using face-to-face contact and the online newsletter associated with the transplant clinic organization appeared to be more effective than strategies not associated with the transplant clinic (Facebook and university website). Findings suggest that using a familiar organization communication method to recruit older chronic disease population may be the most beneficial.

Polyomavirus Reactivation and Immune Responses to Kidney-Specific Self-Antigens in Transplantation.

Humoral immune responses against donor antigens are important determinants of long-term transplant outcomes. Reactivation of the polyomavirus BK has been associated with de novo antibodies against mismatched donor HLA antigens in kidney transplantation. The effect of polyomavirus reactivation (BK viremia or JC viruria) on antibodies to kidney-specific self-antigens is unknown. We previously reported excellent 5-year outcomes after minimization of immunosuppression for BK viremia and after no intervention for JC viruria. Here, we report the 10-year results of this trial (n=193) along with a nested case-control study (n=40) to explore associations between polyomavirus reactivation and immune responses to the self-antigens fibronectin (FN) and collagen type-IV (Col-IV). Consistent with 5-year findings, subjects taking tacrolimus, compared with those taking cyclosporin, had less acute rejection (11% versus 22%, P=0.05) and graft loss (9% versus 22%, P=0.01) along with better transplant function (eGFR 65±19 versus 50±24 ml/min per 1.73 m2, P<0.001) at 10 years. Subjects undergoing immunosuppression reduction for BK viremia had 10-year outcomes similar to those without viremia. In the case-control study, antibodies to FN/Col-IV were more prevalent during year 1 in subjects with polyomavirus reactivation than in those without reactivation (48% versus 11%, P=0.04). Subjects with antibodies to FN/Col-IV had more acute rejection than did those without these antibodies (38% versus 8%, P=0.02). These data demonstrate the long-term safety and effectiveness of minimizing immunosuppression to treat BK viremia. Furthermore, these results indicate that polyomavirus reactivation associates with immune responses to kidney-specific self-antigens that may increase the risk for acute rejection through unclear mechanisms.

Approach to atherosclerotic renovascular disease: 2016.

The management of atherosclerotic renal artery stenosis in patients with hypertension or impaired renal function remains a clinical dilemma. The current general consensus, supported by the results of the Angioplasty and Stenting for Renal Atherosclerotic Lesions and Cardiovascular Outcomes for Renal Artery Lesions trials, argues strongly against endovascular intervention in favor of optimal medical management. We discuss the limitations and implications of the contemporary clinical trials and present our approach and formulate clear recommendations to help with the management of patients with atherosclerotic narrowing of the renal artery.

Iron Treatment Strategies in Dialysis-Dependent CKD.

Iron deficiency is common in patients on chronic dialysis, and most require iron-replacement therapy. In addition to absolute iron deficiency, many patients have functional iron deficiency as shown by a suboptimal response to the use of erythropoietin-stimulating agents. Both absolute and functional iron-deficiency anemia have been shown to respond to intravenous (IV) iron replacement. Although parenteral iron is an efficacious method and superior to standard doses of oral iron in patients on hemodialysis, there are ongoing safety concerns about repeated exposure potentially enhancing infection risk and cardiovascular disease. Each IV iron product is composed of an iron core with a carbohydrate shell. The avidity of iron binding and the type of carbohydrate shell play roles in the safe maximal dose and the frequency and severity of acute infusion reactions. All IV iron products are taken up into the reticuloendothelial system where the shell is metabolized and the iron is stored within tissue ferritin or exported to circulating transferrin. IV iron can be given as large intermittent doses (loading therapy) or in smaller doses at frequent intervals (maintenance dosing regimen). Limited trial data and observational data suggest that a maintenance dosing regimen is more efficacious and possibly safer than loading therapy. There is no consensus regarding the preferred method of iron repletion in patients on peritoneal dialysis, although small studies comparing oral and parenteral iron regimens in these patients have shown the latter to be more efficacious. Use of IV iron in virtually all hemodialysis and many peritoneal dialysis patients remains the standard of care.

Nodular kidney involvement in a patient with idiopathic Sweet's syndrome.

A 40-year-old previously healthy woman presented with a history of painful maculopapular rash, fever and diffuse arthralgia. The skin biopsy was consistent with Sweet's syndrome. Further workup with abdominal CT revealed bilateral hypoenhancing renal lesions involving the cortex and medulla, as well as terminal ileal thickening. Her renal function was preserved. The urinalysis revealed microscopic haematuria and sterile pyuria. Upper and lower gastrointestinal endoscopies were unremarkable and terminal ileal biopsy was normal. The evaluation for secondary causes of Sweet's syndrome was negative. She responded to corticosteroid therapy. A repeat abdominal CT scan two months later showed complete resolution of renal and ileal lesions. One year after the initial presentation the patient is doing well with no recurrent symptoms. We concluded that the abnormal renal findings were most likely due to sterile abscesses in the course of idiopathic Sweet's syndrome.