Search details
1.
Severe Hypocalcemia With Denosumab Among Older Female Dialysis-Dependent Patients.
JAMA
; 331(6): 491-499, 2024 02 13.
Article
in English
| MEDLINE | ID: mdl-38241060
2.
Challenges of Cardio-Kidney Composite Outcomes in Large-Scale Clinical Trials.
Circulation
; 143(9): 949-958, 2021 03 02.
Article
in English
| MEDLINE | ID: mdl-33406882
3.
Clinical Trial Considerations in Developing Treatments for Early Stages of Common, Chronic Kidney Diseases: A Scientific Workshop Cosponsored by the National Kidney Foundation and the US Food and Drug Administration.
Am J Kidney Dis
; 80(4): 513-526, 2022 10.
Article
in English
| MEDLINE | ID: mdl-35970679
4.
Clinical pharmacology considerations for the approval of belimumab for the treatment of adult patients with active lupus nephritis: A regulatory perspective.
Lupus
; 31(4): 424-432, 2022 Apr.
Article
in English
| MEDLINE | ID: mdl-35238725
5.
International consensus definitions of clinical trial outcomes for kidney failure: 2020.
Kidney Int
; 98(4): 849-859, 2020 10.
Article
in English
| MEDLINE | ID: mdl-32998816
6.
Cardiovascular outcome trials in patients with chronic kidney disease: challenges associated with selection of patients and endpoints.
Eur Heart J
; 40(11): 880-886, 2019 03 14.
Article
in English
| MEDLINE | ID: mdl-28431138
7.
Addressing the Need for Clinical Trial End Points in Autosomal Dominant Polycystic Kidney Disease: A Report From the Polycystic Kidney Disease Outcomes Consortium (PKDOC).
Am J Kidney Dis
; 73(4): 533-541, 2019 04.
Article
in English
| MEDLINE | ID: mdl-30600104
8.
Implementing core outcomes in kidney disease: report of the Standardized Outcomes in Nephrology (SONG) implementation workshop.
Kidney Int
; 94(6): 1053-1068, 2018 12.
Article
in English
| MEDLINE | ID: mdl-30360959
9.
African Americans, Kidney Disease, and Drug Development: A Regulatory Perspective.
Am J Kidney Dis
; 72(5 Suppl 1): S33-S36, 2018 11.
Article
in English
| MEDLINE | ID: mdl-30343721
10.
Precision medicine in diabetes and diabetic kidney disease: Regulatory considerations.
Diabetes Obes Metab
; 20 Suppl 3: 19-23, 2018 10.
Article
in English
| MEDLINE | ID: mdl-30294953
11.
Enhancing clinical trial development for pediatric kidney diseases.
Pediatr Res
; 82(5): 727-732, 2017 Nov.
Article
in English
| MEDLINE | ID: mdl-28853726
12.
Innovating and invigorating the clinical trial infrastructure for glomerular diseases.
Kidney Int
; 99(3): 519-523, 2021 03.
Article
in English
| MEDLINE | ID: mdl-33637197
13.
Complete and Partial Remission as Surrogate End Points in Membranous Nephropathy.
J Am Soc Nephrol
; 26(12): 2930-7, 2015 Dec.
Article
in English
| MEDLINE | ID: mdl-26078365
14.
Change in Estimated GFR and Albuminuria as End Points in Clinical Trials: A Viewpoint From the FDA.
Am J Kidney Dis
; 75(1): 4-5, 2020 01.
Article
in English
| MEDLINE | ID: mdl-31672253
15.
DEVELOPING THERAPIES FOR C3G: REPORT OF THE KIDNEY HEALTH INITIATIVE C3G TRIAL ENDPOINTS WORK GROUP.
Clin J Am Soc Nephrol
; 2024 Jun 03.
Article
in English
| MEDLINE | ID: mdl-38829708
16.
Overcoming Barriers to Drug Development in Children with CKD.
Clin J Am Soc Nephrol
; 18(8): 1101-1107, 2023 08 01.
Article
in English
| MEDLINE | ID: mdl-37055225
17.
End Point Considerations for Clinical Trials in Enteric Hyperoxaluria.
Clin J Am Soc Nephrol
; 18(12): 1637-1644, 2023 12 01.
Article
in English
| MEDLINE | ID: mdl-37342976
18.
Roadmap for cardiovascular prevention trials in chronic kidney disease.
Lancet
; 388(10055): 1964-1966, 2016 Oct 22.
Article
in English
| MEDLINE | ID: mdl-27789005
19.
Treating Early-Stage CKD With New Medication Therapies: Results of a CKD Patient Survey Informing the 2020 NKF-FDA Scientific Workshop on Clinical Trial Considerations for Developing Treatments for Early Stages of Common, Chronic Kidney Diseases.
Kidney Med
; 4(4): 100442, 2022 Apr.
Article
in English
| MEDLINE | ID: mdl-35372821
20.
Value of Data Sharing to Advance Drug Development: A Regulatory Perspective.
Ther Innov Regul Sci
; 55(4): 850-852, 2021 07.
Article
in English
| MEDLINE | ID: mdl-33876396