Clinical trials: Chronic Kidney Disease Stage 3 and 4
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
- NCT01704079
- Testing
- CTAP101 30 μg capsules, Sugar pill to CTAP101 30 μg capsules
- Where
- United States
- Volunteers
- 216 people
- Sponsor
- OPKO IP Holdings II, Inc.
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.
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.
Chronic Renal Failure
Change From Baseline to Chronic Kidney Disease Patient Before and After Administration Drug
Chronic renal failure is a syndrome that renal function is decreased, and the patient number is increasing. In addition, patients on dialysis have also increased.
- Trial name
- NCT02378194
- Testing
- HD-003 (800mg/day), HD-003 (1600mg/day)
- Volunteers
- 62 people
- Sponsor
- Hyundai Pharmaceutical Co., LTD.
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
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
The goal of this observational pilot study is to evaluate the investigational AK+ Guard™ software as a medical device (SaMD) for detection of moderate to severe hyperkalemia (serum potassium (K+) ≥ 6.5 mmol/L) in adults with…
- Trial name
- NCT07210021
- Testing
- AK+ Guard™ ECG Application
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- AccurKardia, Inc.
Renal Anemia Associated With Chronic Renal Failure (CRF)
A Study to Investigate the Effect of ASP1517 After Intermittent Oral Dosing in Dialysis Chronic Kidney Disease Patients With Anemia Compared With Darbepoetin as a Reference Drug
This study is to evaluate safety and efficacy of intermittent oral dosing of ASP1517 in dialysis chronic kidney disease patients with anemia.
- Trial name
- NCT01888445
- Testing
- roxadustat, darbepoetin alfa
- Where
- 8 sites in Japan
- Volunteers
- 130 people
- Sponsor
- Astellas Pharma Inc
Anemia, Kidney Disease
42-Day Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
The purpose of this study is to evaluate the dose response (efficacy), pharmacodynamic response, pharmacokinetics, safety, and tolerability of orally administered AKB-6548 in pre-dialysis participants with anemia with repeat…
- Trial name
- NCT01381094
- Testing
- AKB-6548
- Where
- 28 sites in United States
- Volunteers
- 93 people
- Sponsor
- Akebia Therapeutics
Chronic Kidney Diseases
Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe Chronic Kidney Disease (CKD)
This Phase 3, randomized, Double-blind, placebo-controlled, 2-arm, parallel-group, multicenter study with randomized withdrawal will evaluate the efficacy, safety, and durability of KBP-5074 in adult participants who have stage…
- Trial name
- Clarion-CKD (NCT04968184)
- Testing
- KBP-5074
- Where
- 215 sites in United States, Australia and 20 more
- Volunteers
- 666 people
- Sponsor
- Novo Nordisk A/S
Chronic Kidney Disease, Chronic Kidney Disease, Stage 3 (Moderate)
Study to Assess PK, Safety and Tolerability in Patients With DM and CKD
An open-label, phase IB, multi-center study evaluating DM199 in subjects with Type 1 Diabetes or Type 2 Diabetes and Stage 3 or 4 Chronic Kidney Disease.
- Conditions
- Chronic Kidney Disease, Chronic Kidney Disease, Stage 3 (Moderate), Chronic Kidney Disease, Stage 4 (Severe), Diabetes
- Trial name
- NCT03795389
- Testing
- DM199
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- DiaMedica Therapeutics Inc
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
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, 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.
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
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
Acute Kidney Injury (Nontraumatic)
Open-Label Safety, Tolerability, PK Study of IV CXA-10 Emulsion in Subjects in Chronic Kidney Injury
The main purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of CXA-10, at potentially therapeutic doses, in the target patient population comprised of subjects with Stage 3 and 4 chronic…
- Trial name
- NCT02248051
- Testing
- CXA-10
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Complexa, Inc.