Clinical trials: CKD
Fabry Disease, Chronic Kidney Disease, Stage IV (Severe)
Severe Renal Disease Study in Fabry Patients Treated With Fabrazyme
This study was designed to determine appropriate treatment with Fabrazyme at a biweekly dose of either 1 mg/kg or 3 mg/kg in a population of patients with severe renal disease burden.
- Trial name
- NCT00837824
- Testing
- Fabrazyme (agalsidase beta)
- Where
- 9 sites in United States
- Volunteers
- 20 people
- Sponsor
- Genzyme, a Sanofi Company
Pediatric Hypertension With or Without CKD
Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD
To assess efficacy, safety and tolerability of valsartan when comparing two doses of valsartan in reducing and controlling blood pressure in children with hypertension with or without CKD.
- Trial name
- NCT01617681
- Testing
- VAL489
- Where
- 27 sites in Belgium, Brazil and 7 more
- Volunteers
- 127 people
- Sponsor
- Novartis Pharmaceuticals
Safety Issues, Chronic Kidney Diseases
Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease
The benefits of renin angiotensin system (RAS) blockers and diuretics for blood pressure control are well-established in chronic kidney diseases (CKD) patients; however, these agents may become hazardous on "sick-days" that lead…
- Trial name
- NCT03141905
- Testing
- Sick-Day Protocol, Usual Care
- Where
- United States
- Volunteers
- 342 people
- Sponsor
- University of Maryland, Baltimore
Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism
This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study in children with stage 3-4 chronic kidney disease (CKD), secondary hyperparathyroidism (SHPT) and vitamin D insufficiency.
- Conditions
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Vitamin d Deficiency, Secondary Hyperparathyroidism
- Trial name
- NCT05543928
- Testing
- CTAP101
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- OPKO Health, Inc.
Anemia
Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients
The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients.
- Trial name
- NCT00721188
- Testing
- Venofer
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- American Regent, Inc.
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)
A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)
The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT associated with stage 5 CKD receiving Peritoneal…
- Trial name
- NCT04064827
- Testing
- Paricalcitol
- Where
- 15 sites in United States, Puerto Rico
- Volunteers
- 2 people
- Sponsor
- AbbVie
Secondary Hyperparathyroidism
FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease
FGF-23 is a newly described protein that is an important regulator of phosphorus in the body. This protein increases in people with kidney disease and people who need dialysis have very high levels of FGF-23 in the blood.
- Trial name
- NCT00999037
- Testing
- Sevelamer Carbonate
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- University of California, Los Angeles
Anaemia
Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)
This is an international, multicenter trial, evaluating pharmacokinetics (PK) (4 weeks), safety (52 weeks), and hemoglobin (Hgb) response (52 weeks) to daprodustat in children and adolescent participants with anemia associated…
- Trial name
- ASCEND-P (NCT05682326)
- Testing
- Daprodustat
- Where
- 4 sites in Japan, South Korea
- Volunteers
- 4 people
- Sponsor
- GlaxoSmithKline
Hyperphosphatemia, Chronic Kidney Disease
An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease
Objective: In hyperphosphatemic pediatric participants with chronic kidney disease (CKD) to Evaluate the safety and tolerability of sevelamer carbonate Evaluate the efficacy of sevelamer carbonate on the control of serum…
- Trial name
- NCT01574326
- Testing
- Sevelamer carbonate
- Where
- 32 sites in United States, France and 3 more
- Volunteers
- 101 people
- Sponsor
- Genzyme, a Sanofi Company
Pediatric Heart Transplantation, Immunosuppression
Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score
The TEAMMATE Trial will enroll 210 pediatric heart transplant patients from 25 centers at 6 months post-transplant and follow each patient for 2.5 years.
- Conditions
- Pediatric Heart Transplantation, Immunosuppression, Chronic Kidney Diseases, Cardiac Allograft Vasculopathy
- Trial name
- TEAMMATE (NCT03386539)
- Testing
- Everolimus, Tacrolimus, Mycophenolate Mofetil
- Where
- 25 sites in United States
- Volunteers
- 211 people
- Sponsor
- Boston Children's Hospital
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease)
The primary objective of the study is to assess the long term safety of treatment with tolvaptan in children and adolescents with autosomal dominant polycystic kidney disease (ADPKD).
- Trial name
- NCT02964273
- Testing
- Tolvaptan
- Where
- 20 sites in Belgium, Germany and 2 more
- Volunteers
- 91 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Secondary Hyperparathyroidism-Chronic Kidney Disease
Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
Primary Objective: Evaluated the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH). Secondary Objectives: Evaluated the safety profile of Hectorol® capsules versus Rocaltrol®…
- Trial name
- NCT02859896
- Testing
- Doxercalciferol (GZ427397), Calcitriol
- Where
- 23 sites in United States, Chile
- Volunteers
- 21 people
- Sponsor
- Sanofi
Chronic Kidney Disease, Hyperphosphatemia
A Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis
The purpose of this study is to summarize the percentage of participants achieving age-specific Kidney Disease Outcomes Quality Initiative (KDOQI) targets for serum phosphorus in hyperphosphatemic children and adolescents with…
- Trial name
- NCT01696279
- Testing
- Lanthanum Carbonate, Calcium Carbonate
- Where
- 22 sites in Argentina, Chile and 7 more
- Volunteers
- 63 people
- Sponsor
- Shire
Secondary Hyperparathyroidism, End-Stage Renal Disease
Study to Evaluate Safety of Vitamin D Receptor Activators in Patients Ages 0 to 16 With Chronic Kidney Disease Stage 5 Receiving Peritoneal Dialysis Within Current Clinical Practice
The objective of this study was to observe the safety of paricalcitol utilization in pediatric participants (ages 0 to 16 years old) being treated for secondary hyperparathyroidism (SHPT).
- Trial name
- NCT01134315
- Testing
- Paricalcitol, Calcitriol
- Where
- 18 sites in United States
- Volunteers
- 61 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Chronic Kidney Disease, Secondary Hyperparathyroidism
A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
This is a study to evaluate the safety and pharmacokinetics in pediatric patients with secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of hemodialysis.
- Trial name
- NCT02833857
- Testing
- Etelcalcetide
- Where
- 13 sites in United States, Belgium and 4 more
- Volunteers
- 11 people
- Sponsor
- Amgen
Hyperuricemia, Chronic Kidney Diseases
Uric Acid Reduction as a Novel Treatment for Pediatric Chronic Kidney Disease
Aim 1. To determine the effect of Allopurinol treatment on renal function (glomerular filtration rate, GFR) in pediatric chronic kidney disease (CKD) patients with high uric acid levels (hyperuricemia). Aim 2.
- Trial name
- NCT03865407
- Testing
- Allopurinol
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Virginia Commonwealth University
End Stage Renal Disease
Triferic Pediatric Pharmacokinetic Protocol
The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis (CKD-5HD).
- Trial name
- NCT02595437
- Testing
- Triferic
- Where
- 9 sites in United States
- Volunteers
- 22 people
- Sponsor
- Rockwell Medical Technologies, Inc.
Hyperphosphatemia, End Stage Renal Disease
A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP
The study is designed to evaluate the ability of tenapanor alone or in combination with sevelamer to achieve serum phosphorus concentration (sP) within the population reference range (sP >2.5 and ≤4.5 mg/dL) in patients with…
- Trial name
- NORMALIZE (NCT03988920)
- Testing
- Tenapanor, Sevelamer Carbonate
- Where
- United States
- Volunteers
- 172 people
- Sponsor
- Ardelyx
Chronic Kidney Disease, Bloodpressure
Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD
The transition from chronic kidney disease (CKD) to end-stage renal disease ESRD is a vulnerable and challenging period of time for patients and providers.
- Conditions
- Chronic Kidney Disease, Bloodpressure, Hypertension
- Trial name
- PERFORMANCE (NCT02975505)
- Testing
- Strict blood pressure control
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- University of California, San Francisco
Anemia of Chronic Kidney Disease
Vitamin D as a Modifier of Serum Hepcidin in Children With Chronic Kidney Disease
This research is being done to study the effectiveness of vitamin D (cholecalciferol) to modify hepcidin levels in children with chronic kidney disease (CKD). Anemia is a common problem in children with CKD.
- Trial name
- D-fense (NCT01532349)
- Testing
- Cholecalciferol
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Johns Hopkins University