Clinical trials: Chronic Kidney Disease, Stage 4
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
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
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.
Anaemia
4 Week Correction Study in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Undergoing Dialysis
This is a four-week Phase IIa, randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of GSK1278863 in approximately 68 subjects with anemia…
- Trial name
- NCT01587898
- Testing
- GSK1278863
- Where
- 55 sites in United States, Canada and 1 more
- Volunteers
- 72 people
- Sponsor
- GlaxoSmithKline
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.
Hyperphosphatemia, End-Stage Renal Disease
A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease
This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs.
- Trial name
- NCT01074125
- Testing
- ferric citrate
- Where
- 16 sites in United States, Puerto Rico
- Volunteers
- 154 people
- Sponsor
- Keryx Biopharmaceuticals
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.
End Stage Renal Disease
Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients
To characterize the GORE® Hybrid Vascular Graft as compared to non-heparin bonded synthetic vascular grafts in terms of the prevalence and persistence of anti-platelet factor 4 / heparin antibodies (anti-PF4 / H antibodies).
- Trial name
- NCT02165761
- Testing
- GORE® Hybrid Vascular Graft, Non-heparin bonded synthetic graft
- Where
- 4 sites in United States
- Volunteers
- 42 people
- Sponsor
- W.L.Gore & Associates
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
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
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.
Anemia
A Study of NeoRecormon in Patients With Chronic Kidney Disease.
This 2 arm study will compare the level of anemia, and the decline in renal function, between patients receiving NeoRecormon, and those not receiving it.
- Trial name
- NCT00437723
- Testing
- epoetin beta [NeoRecormon]
- Where
- 2 sites in Serbia
- Volunteers
- 90 people
- Sponsor
- Hoffmann-La Roche
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
Renal Insufficiency
Evaluation of the Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Without Exposure to Gadolinium Based Contrast Agents (GBCA)
The objective of this long term study is to prospectively evaluate the incidence of NSF in patients with severe CKD or kidney failure including patients undergoing dialysis (stages 4 and 5 i.e., with an eGFR below 30)who have not…
- Trial name
- NCT00773409
- Where
- United States
- Volunteers
- 405 people
- Sponsor
- Bracco Diagnostics, Inc
Healthy Volunteers
Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers
The main purpose of this study is to evaluate the effect of single oral therapeutic and supratherapeutic doses of AKB-6548 on the QT interval.
- Trial name
- NCT02062203
- Testing
- AKB-6548 (therapeutic dose), AKB-6548 (supratherapeutic dose), Moxifloxacin
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Akebia Therapeutics
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
Anemia in Chronic Kidney Disease
An Exploratory Study to Evaluate FMX-8 to Treat Anemia in CKD
FMX-8 is a new type of drug being tested for the treatment of anemia in chronic illnesses.
- Trial name
- NCT02228655
- Testing
- FMX-8
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- FerruMax Pharmaceuticals, Inc.