Clinical trials: Chronic Kidney Disease (Stage 3)
Type 2 Diabetes Mellitus, Chronic Kidney Disease
Fasiglifam in Type 2 Diabetic Subjects With Chronic Kidney Disease Stage 4 or 5 on Hemodialysis
To evaluate the efficacy of fasiglifam 50 mg once daily compared to placebo on glycemic control as measured by glycosilated haemoglobin (HbA1c) over a 16-week treatment period in participants with Type 2 Diabetes Mellitus (T2DM)…
- Trial name
- NCT02015780
- Testing
- Fasiglifam, Antihyperglycemic therapy
- Where
- 30 sites in United States, Bulgaria and 5 more
- Sponsor
- Takeda
Healthy Volunteers, Chronic Kidney Disease
A Study of RBT-1 in Healthy Volunteers and Subjects With Stage 3/4 Chronic Kidney Disease
This is a Phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effect of RBT-1 in healthy volunteers and in subjects with Stage 3/4 CKD.
- Trial name
- NCT03893799
- Testing
- RBT-1
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Renibus Therapeutics, 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
Phase 1 Study of Allogeneic Bone Marrow-Derived Mesenchymal Stem Cells in Chronic Kidney Disease
The goal of this clinical trial is to evaluate the safety of Cellgram-CKD in patients with chronic kidney disease over 12 months after three administrations.
- Trial name
- NCT05042206
- Testing
- Cellgram-CKD
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- Pharmicell Co., Ltd.
Anemia
Combined Single / Multiple Dose Escalation Study in Patients With Renal Anemia Due to CKD (Chronic Kidney Disease)
The drug that is under investigation during this study is BAY85-3934 which is intended to be used as a treatment for patients suffering from renal anemia due to chronic kidney disease (stage 3 and 4).
- Trial name
- NCT01332942
- Testing
- BAY85-3934
- Where
- 11 sites in Germany, United Kingdom
- Volunteers
- 44 people
- Sponsor
- Bayer
Anemia of Chronic Kidney Disease
A Pilot Study of KRX-0502 (Ferric Citrate, Administered Without Food, in Treating Iron-deficiency Anemia
The objective of the study is to evaluate the efficacy and safety of KRX-0502, administered without food, in treating iron deficiency anemia in subjects with stage 3 to 5 non-dialysis dependent chronic kidney disease (NDD-CKD).
- Trial name
- NCT02128074
- Testing
- KRX-0502
- Where
- 3 sites in Israel
- Volunteers
- 32 people
- Sponsor
- Keryx Biopharmaceuticals
Anemia, Dialysis-Dependent Chronic Kidney Disease
Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)
A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with dialysis-dependent chronic kidney disease (DD-CKD)
- Trial name
- NCT02892149
- Testing
- Vadadustat, Darbepoetin alfa
- Where
- 278 sites in United States, Argentina and 16 more
- Volunteers
- 3,554 people
- Sponsor
- Akebia Therapeutics
Stage 3 Chronic Kidney Disease
Safety & Tolerability Study of CTP-499 in Patients With Moderate Chronic Kidney Disease
This study is being conducted to evaluate the safety and tolerability of treatment with CTP-499 in non-dialysis patients associated with moderate chronic kidney disease.
- Trial name
- NCT01460199
- Testing
- CTP-499
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- Concert Pharmaceuticals
Chronic Renal Failure, Chronic Kidney Disease
Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
The purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA)…
- Conditions
- Chronic Renal Failure, Chronic Kidney Disease, Anemia
- Trial name
- PEARL 1 (NCT00598273)
- Testing
- peginesatide, Darbepoetin alfa
- Where
- 72 sites in United States, Puerto Rico
- Volunteers
- 490 people
- Sponsor
- Affymax
End Stage Kidney Disease
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1: Phase 2b is a dose-finding study for CSL300 vs placebo.
- Trial name
- POSIBIL6ESKD (NCT05485961)
- Testing
- CSL300
- Where
- 566 sites in United States, Argentina and 33 more
- Volunteers
- 3,110 people
- Sponsor
- CSL Behring
Secondary Hyperparathyroidism, Renal Failure
Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism
The purpose of this study is to demonstrate the safety and effectiveness of Hectorol® (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney disease (CKD) with secondary hyperparathyroidism who…
- Conditions
- Secondary Hyperparathyroidism, Renal Failure, Chronic Renal Insufficiency
- Trial name
- NCT00123461
- Testing
- Hectorol (doxercalciferol capsules), 0.5mcg
- Where
- 19 sites in United States, Puerto Rico
- Volunteers
- 70 people
- Sponsor
- Genzyme, a Sanofi Company
Chronic Kidney Disease, Renal Dialysis
Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis
This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 for long-term dosing in chronic kidney disease and hyperphosphatemia patients on hemodialysis.
- Conditions
- Chronic Kidney Disease, Renal Dialysis, Renal Insufficiency, Hyperphosphatemia
- Trial name
- NCT00892749
- Testing
- ASP1585
- Where
- 4 sites in Japan
- Volunteers
- 248 people
- Sponsor
- Astellas Pharma Inc
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
- Trial name
- NCT01651000
- Testing
- CTAP101 30 μg capsules, Sugar pill to CTAP101 30 μg capsules
- Where
- United States
- Volunteers
- 213 people
- Sponsor
- OPKO IP Holdings II, Inc.
Anemia of Chronic Kidney Disease
CKD-11101 Phase 3 SC Study
The aim of this study was to compare and evaluate efficacy and safety of subcutaneous CKD-11101 versus Darbepoetin alfa in patients who have renal anemia not on dialysis.
- Trial name
- NCT03431623
- Testing
- CKD-11101(Darbepoetin alfa), NESP(Darbepoetin alfa)
- Volunteers
- 248 people
- Sponsor
- Chong Kun Dang Pharmaceutical
CKD Anemia
A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis
The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.
- Trial name
- NCT01750190
- Testing
- Roxadustat
- Where
- 145 sites in United States, Argentina and 14 more
- Volunteers
- 922 people
- Sponsor
- Kyntra Bio
Chronic Renal Failure Requiring Hemodialysis
A Phase 3, Long-Term Safety Study of Subcutaneous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME -Anemia Management With Epoetin
To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal…
- Trial name
- AiME - 04 (NCT01628120)
- Testing
- Epoetin Hospira
- Where
- 115 sites in United States
- Volunteers
- 170 people
- Sponsor
- Pfizer
Chronic Kidney Disease
Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Participants With Chronic Kidney Disease (CKD), Stages 3 and 4
This study was conducted to assess the pharmacokinetic (PK) profile, safety, and tolerability in participants with Stage 3 and 4 Chronic Kidney Disease (CKD) following a single oral dose of Vadadustat.
- Trial name
- NCT04707573
- Testing
- Vadadustat
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Akebia Therapeutics
Secondary Hyperparathyroidism, Chronic Kidney Disease
A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
This is a phase 3 trial of etelcalcetide in pediatric participants with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) on hemodialysis.
- Trial name
- NCT03633708
- Testing
- Etelcalcetide, Standard of Care
- Where
- 43 sites in United States, Argentina and 8 more
- Volunteers
- 56 people
- Sponsor
- Amgen
Renal Insufficiency, Chronic, Iron-Deficiency Anemia
Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease
To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA in subjects with CKD
- Trial name
- AEGIS-CKD (NCT02968368)
- Testing
- Ferric maltol
- Where
- 27 sites in United States
- Volunteers
- 167 people
- Sponsor
- Shield Therapeutics
Kidney Transplant Rejection
Study of Tegoprubart Efficacy and Safety Compared With Tacrolimus in Kidney Transplantation
This study will evaluate the efficacy and safety of tegoprubart compared with tacrolimus in adult participants undergoing first kidney transplantation.
- Trial name
- LEGACY (NCT07835581)
- Testing
- Tegoprubart, Tacrolimus
- Volunteers
- 620 people
- Sponsor
- Eledon Pharmaceuticals