Clinical trials: Stage 5 Chronic Kidney Diseases
End-Stage Renal Disease, Secondary Hyperparathyroidism
A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages 10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving peritoneal dialysis or hemodialysis and being treated…
- Trial name
- NCT01382212
- Testing
- paricalcitol
- Volunteers
- 13 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Chronic Kidney Disease Stage 5 on Dialysis
Desidustat in the Treatment of Anemia in CKD on Dialysis Patients
A phase 3, multicenter, open-label, randomized, active-controlled study to evaluate the efficacy and safety of Desidustat Tablet versus Epoetin alfa Injection for the treatment of anemia in patients with CKD on dialysis. (DREAM-D)
- Trial name
- DREAM-D (NCT04215120)
- Testing
- Desidustat Oral Tablet, Epoetin Alfa
- Where
- 7 sites in India
- Volunteers
- 392 people
- Sponsor
- Zydus Lifesciences Limited
Chronic Kidney Disease (CKD) Stage 5, Hypertrophy, Left Ventricular
The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5
To evaluate the effects of paricalcitol injection on cardiac structure and function over 48 weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who have left ventricular hypertrophy (LVH).
- Trial name
- PRIMO II (NCT00616902)
- Testing
- paricalcitol injection 4 mcg/mL
- Where
- 76 sites in United States, Australia and 11 more
- Volunteers
- 12 people
- Sponsor
- Abbott
Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
PR-0164 First in Human Clinical Trial of the PAVmed PortIO Intraosseous Infusion System
The PortIO is intended to provide non-emergent vascular access in chronic kidney disease (CKD) patients where preservation of venous anatomy is desired and iatrogenic damage to the veins should be avoided and/or patients with…
- Conditions
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Poor Vascular Access
- Trial name
- NCT06037265
- Testing
- PAVmed PortIO™ Intraosseous Infusion System
- Where
- 4 sites in Colombia
- Volunteers
- 15 people
- Sponsor
- PAVmed Inc.
Chronic Kidney Disease Stage 5
A Single Arm, Multi-Center Study To Evaluate The Intelligent Dialysis Assistant (IDA)
This is a multi-center, open label, cross-over clinical study. A total of 18 subjects will be enrolled to use the IDA for every peritoneal dialysis exchange for 14 days.
- Trial name
- NCT04808011
- Testing
- Intelligent Dialysis Assistant (IDA)
- Where
- 3 sites in Israel
- Volunteers
- 20 people
- Sponsor
- liberDi Ltd.
Chronic Kidney Disease, Not on Dialysis
Safety and Tolerability Study of MCI-196
The objective of this study is to assess the safety and tolerability of colestilan (MCI-196) in paediatric subjects (aged 2 years to <18 years) with CKD stages 3b to 5, diagnosed with hyperphosphataemia, who are not on dialysis.
- Conditions
- Chronic Kidney Disease, Not on Dialysis, Hyperphosphatemia, Paediatric
- Trial name
- NCT01818687
- Testing
- colestilan
- Where
- United Kingdom
- Volunteers
- 4 people
- Sponsor
- Tanabe Pharma Corporation
Chronic Kidney Disease Stage V
A Prospective, Open-label, Multi-center Pilot Study to Evaluate the Safety, Feasibility and Usability of the IDA
This is a multi-center, open label, cross-over clinical study. A total of 15 subjects will be enrolled to use the IDA for every peritoneal dialysis exchange for 14 days.
- Trial name
- CSP-027-21 (NCT05342935)
- Testing
- Inteligent Dialysis Assistant (IDA)
- Volunteers
- 15 people
- Sponsor
- liberDi Ltd.
End Stage Renal Disease, Hyperphosphatemia
Phosphate Kinetic Modeling
Cardiovascular disease is a major cause of death in hemodialysis (HD) patients and is associated with widespread vascular calcification.
- Trial name
- PKM (NCT01003223)
- Testing
- Computer algorithm management of hyperphosphatemia
- Where
- United States
- Volunteers
- 190 people
- Sponsor
- Fresenius Medical Care North America
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
Anemia
An Observational Study of Mircera in Patients With Chronic Renal Anemia on Dialysis (CKD Stage V) or Not on Dialysis (CKD Stage III-IV)
This observational study will evaluate the use and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in anemia patients with chronic kidney disease (CKD) stage III-IV not on dialysis or CKD stage V on dialysis.
- Trial name
- NCT01667380
- Where
- Montenegro
- Volunteers
- 78 people
- Sponsor
- Hoffmann-La Roche
Chronic Kidney Disease, Hyperlipidemia
Efficacy and Safety of Simvast Controlled Release (CR) and Zocor in Chronic Kidney Disease(CKD) Stage 3, 4 and 5 Patients With Hyperlipidemia
Study design Multicenter, double-dummy, double-blinded, randomized, Phase 4 study Patients will be randomized to either a study group or a control group in a 1:1 ratio, and will be orally administered the assigned drugs Study…
- Trial name
- HM-SIM4 (NCT01564875)
- Testing
- Simvast CR, Zocor
- Where
- 7 sites in South Korea
- Volunteers
- 122 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Kidney Insufficiency, Secondary Hyperparathyroidism
Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice
The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® (paricalcitol) injection and paricalcitol capsules in real-life clinical practice.
- Trial name
- TOP (NCT01083849)
- Where
- 87 sites in Austria, Germany
- Volunteers
- 761 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Chronic Kidney Disease, Dialysis
Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
The primary objective of this study is to demonstrate the long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia.
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- Trial name
- NCT00772382
- Testing
- MCI-196
- Where
- 21 sites in United States, Canada
- Volunteers
- 116 people
- Sponsor
- Tanabe Pharma Corporation
Diabetic Nephropathies
A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy
PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791 will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure, improving renal function.
- Trial name
- NCT01200394
- Testing
- PF-00489791
- Where
- 160 sites in United States, Australia and 13 more
- Volunteers
- 256 people
- Sponsor
- Pfizer
Chronic Kidney Disease, End-stage Renal Disease
MONITOR-CKD5 - Multi-level Evaluation of Anaemia Treatment, Outcomes, and Determinants in Chronic Kidney Disease Stage 5
MONITOR-CKD5 is an observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the treatment of renal anaemia with biosimilar epoetin alfa in Stage 5 CKD patients requiring…
- Conditions
- Chronic Kidney Disease, End-stage Renal Disease, Anaemia
- Trial name
- MONITOR-CKD5 (NCT01121237)
- Testing
- Recombinant human erythropoietin alfa (biosimilar)
- Where
- 95 sites in Austria, France and 8 more
- Volunteers
- 2,086 people
- Sponsor
- Sandoz
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 (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
End-Stage Kidney Disease
Evaluate the Survival Benefits of Zemplar Versus Calcijex in Subjects w/ Stage V Chronic Kidney Disease on Hemodialysis
To evaluate the survival benefit associated with Zemplar therapy as compared to Calcijex for the treatment of secondary hyperparathyroidism in subjects with Stage V chronic kidney disease on hemodialysis as measured by time to…
- Trial name
- NCT00062699
- Testing
- Zemplar (paricalcitol injection), Calcijex
- Where
- 60 sites in United States
- Volunteers
- 2,200 people
- Sponsor
- Abbott
Chronic Kidney Disease, Dialysis
A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia
This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the third period is a placebo-controlled withdrawal…
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- Trial name
- NCT00506441
- Testing
- MCI-196
- Where
- 39 sites in United States, Puerto Rico
- Volunteers
- 245 people
- Sponsor
- Tanabe Pharma Corporation
Chronic Kidney Disease Stage 3, Anemia
Desidustat in the Treatment of Anemia in CKD
This is a phase III, multicenter, multi-country, open-label, randomized, active-controlled clinical trial to evaluate the efficacy and safety of Desidustat versus Darbepoetin for the treatment of anemia in patients with CKD who…
- Conditions
- Chronic Kidney Disease Stage 3, Anemia, Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 5
- Trial name
- DREAM-ND (NCT04012957)
- Testing
- Desidustat Oral Tablet, Darbepoetin Alfa
- Where
- 32 sites in India
- Volunteers
- 588 people
- Sponsor
- Zydus Lifesciences Limited