Clinical trials: CKD Stage 4
Anemia
A Study of MIRCERA in Participants With Chronic Kidney Disease Stage 3-4 and Not on Dialysis
An observational, longitudinal, multi-center, non-interventional study in participants with chronic kidney disease (CKD) stage 3-4, assessed by Modification of Diet in Renal Disease (MDRD) to collect data regarding safety and…
- Trial name
- NCT02567188
- Testing
- MIRCERA
- Where
- 20 sites in Sweden
- Volunteers
- 144 people
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers, Chronic Kidney Disease
A Study of RBT-9 in Healthy Volunteers and Volunteers 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-9 in healthy volunteers and in subjects with Stage 3/4 CKD.
- Trial name
- NCT04072861
- Testing
- RBT-9
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Renibus Therapeutics, Inc.
Secondary Hyperparathyroidism
A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis
This study will measure serum levels of the active Vitamin D compound that circulates in hemodialysis subjects treated with either doxercalciferol injection (Hectorol®) or Zemplar® (paricalcitol injection).
- Trial name
- NCT00454350
- Testing
- Hectorol (doxercalciferol injection), Zemplar (Paricalcitol injection)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Genzyme, a Sanofi Company
Anemia of Chronic Kidney Disease
Phase 2a Study to Evaluate PRS-080 in Anemic Chronic Kidney Disease Patients
Anticalin® proteins are engineered human proteins that are able to bind specific target molecules. The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin and is intended for the treatment of…
- Trial name
- NCT03325621
- Testing
- PRS-080#022-DP
- Where
- 6 sites in Czechia, Germany
- Volunteers
- 11 people
- Sponsor
- Pieris Pharmaceuticals GmbH
Chronic Kidney Disease, Anemia
Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis
The primary objective of the study is to evaluate the safety, tolerability, and pharmacodynamic effects of different oral doses of roxadustat administered 2 times a week (BIW) or 3 times a week (TIW) for up to 4 weeks to…
- Trial name
- NCT00761657
- Testing
- Roxadustat
- Where
- 34 sites in United States
- Volunteers
- 117 people
- Sponsor
- Kyntra Bio
Chronic Kidney Disease (Stages 4 and 5), Kidney Disease
Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
The purpose of this research is to evaluate outcomes of physiologic insulin re-sensitization (PIR) in patients with Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM).
- Conditions
- Chronic Kidney Disease (Stages 4 and 5), Kidney Disease, Type 2 Diabetes
- Trial name
- NCT07187479
- Testing
- Physiologic Insulin Resensitization (PIR)
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- Well Cell Global
Anemia, Kidney Disease
Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia
The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.
- Trial name
- NCT01235936
- Testing
- AKB-6548
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Akebia Therapeutics
Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Insufficiency
Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency
An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in…
- Conditions
- Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Insufficiency, CKD Stage 3, CKD Stage 4
- Trial name
- NCT03588884
- Testing
- Calcifediol Oral Capsule, Calcifediol Oral Product, Cholecalciferol
- Where
- 3 sites in United States
- Volunteers
- 69 people
- Sponsor
- OPKO Health, Inc.
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.
Anaemia
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GSK1278863 in Japanese Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease
This study aims to characterize the relationship between dose of GSK1278863 and hemoglobin (Hgb) response in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease (CKD).
- Trial name
- NCT02019719
- Testing
- GSK1278863
- Where
- 21 sites in Japan
- Volunteers
- 97 people
- Sponsor
- GlaxoSmithKline
Anemia, Chronic Kidney Disease
20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with Chronic Kidney Disease (pre-dialysis) with anemia with dosing for 20 weeks.
- Trial name
- NCT01906489
- Testing
- AKB-6548
- Where
- 47 sites in United States
- Volunteers
- 210 people
- Sponsor
- Akebia Therapeutics
Chronic Kidney Diseases
A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease
This parallel-group, randomized, placebo-controlled study will examine the incidence and severity of acute kidney injury (AKI) in patients with chronic kidney disease (CKD) stage III/IV following an i.v.
- Trial name
- NCT03119662
- Testing
- Visipaque
- Where
- 29 sites in United States, Belgium and 4 more
- Volunteers
- 4 people
- Sponsor
- GE Healthcare
Hypertension, Renal Insufficiency, Chronic
A Research Study to Show Aprocitentan is Efficacious and Safe to Treat Patients With Uncontrolled Blood Pressure and Chronic Kidney Disease.
The purpose of this research study is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to the background antihypertensive therapy in patients with uncontrolled blood pressure and chronic kidney…
- Trial name
- INSPIRE-CKD (NCT04162366)
- Testing
- Aprocitentan 25 mg
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Secondary Hyperparathyroidism
A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis
Hectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic…
- Trial name
- NCT00418600
- Testing
- Hectorol® (doxercalciferol capsules), doxercalciferol capsules, Hectorol®, doxercalciferol capsules, Hectorol® capsules
- Where
- 8 sites in United States
- Volunteers
- 36 people
- Sponsor
- Genzyme, a Sanofi Company
Anemia
A Study of MIRCERA for the Intrapetient Variability of Hemoglobin Levels in Patients With Chronic Renal Anemia (RIVAL)
This retrospective observational study will assess the incidence of hemoglobin cycling in chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera (methoxy polyethylene glycol-epoetin beta).
- Trial name
- NCT01356589
- Where
- 33 sites in Greece
- Volunteers
- 1,288 people
- Sponsor
- Hoffmann-La Roche
Chronic Kidney Disease, Secondary Hyperparathyroidism
Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects
This study will investigate how the levels of a single dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with Stage…
- Conditions
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency, Chronic Renal Failure
- Trial name
- NCT00888069
- Testing
- CTAP101 Capsules, CTAP101 Injection
- Where
- 12 sites in United States
- Volunteers
- 28 people
- Sponsor
- OPKO IP Holdings II, Inc.
Chronic Kidney Diseases, Chronic Kidney Disease stage3
Living With CKD: An E-Learning Platform for Adolescents With CKD About the Disease and Its Management
Leveraging a unique combination of synchronized web and mobile applications, this 3 year SBIR Phase II project will fully develop and pilot test My Kidney Guru-a program that will offer pediatric patients with CKD developmentally…
- Conditions
- Chronic Kidney Diseases, Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage V
- Trial name
- CKD Delp (NCT05630729)
- Testing
- My Kidney Guru
- Where
- 2 sites in United States
- Volunteers
- 67 people
- Sponsor
- 3-C Institute for Social Development
Hyperkalaemia, Chronic Kidney Disease
Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study
This is an open-label, randomised study in participants with chronic kidney disease (CKD) treated for hyperkalaemia (HK) whilst in hospital.
- Trial name
- CONTINUITY (NCT05347693)
- Testing
- Sodium Zirconium Cyclosilicate (SZC), Local standard of care
- Where
- 28 sites in Belgium, France and 4 more
- Volunteers
- 186 people
- Sponsor
- AstraZeneca
Chronic Kidney Disease, Diabetic Nephropathy
A Study of Atrasentan on Reducing Albuminuria in Type 2 Diabetic Nephropathy Treated With Renin-Angiotensin System Inhibitors
The study objective is to investigate the effects of three low doses of atrasentan on urinary albumin/creatinine ratio (UACR) levels in subjects with Type 2 diabetic nephropathy.
- Trial name
- NCT00920764
- Testing
- 0.25 mg Atrasentan QD, 0.75 mg Atrasentan QD, 1.75 mg Atrasentan QD
- Where
- 28 sites in United States, Puerto Rico
- Volunteers
- 92 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Liver Cirrhosis
A Study to Investigate the Blood Concentrations of 4 Different Oral Doses of Zibotentan in Healthy Non-Asian and Japanese Participants
This study aim to assess the Pharmacokinetics of Zibotentan in Healthy Non-Asian and Japanese Participants.
- Trial name
- NCT06715670
- Testing
- Zibotentan
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AstraZeneca