Clinical trials: Chronic Kidney Disease Stage V
Chronic Kidney Disease Stage 5 (Dialysis Dependent)
A Randomized, Comparative, Open-label Study of IV Monofer® Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With IV Iron Sucrose in Subjects With CKD-5D
The purpose of this study is to compare the efficacy and safety of intravenous iron isomaltoside 1000 with intravenous iron sucrose in patients suffering from Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).
- Trial name
- NCT01222884
- Testing
- Monofer, Iron sucrose
- Where
- India
- Volunteers
- 351 people
- Sponsor
- Pharmacosmos A/S
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
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)
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
Paricalcitol Injection Phase II Trial
The PK and tolerability of paricalcitol after repeated intravenous administration for 2 weeks (total 6 doses at every HD session) are studied in subjects with 2°HPT who are receiving HD 3 times a week for stable chronic renal…
- Trial name
- NCT00646932
- Testing
- paricalcitol
- Where
- 10 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Abbott
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
Kidney Failure, Chronic
Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis
To show non-inferiority in the incidence rates of elevated calcium-phosphorus product between two treatment groups: 1) a group having an initial dose based on baseline PTH (baseline iPTH/80) and 2) a group having a starting dose…
- Trial name
- NCT00091481
- Testing
- Zemplar
- Where
- 19 sites in Greece
- Volunteers
- 201 people
- 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
Kidney Disease
Zemplar® Capsule in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects on Hemodialysis or Peritoneal Dialysis
The objective of this study is to determine the safety and efficacy of Zemplar® Capsule versus placebo, in decreasing elevated intact parathyroid hormone levels in chronic kidney disease stage 5 subjects with secondary…
- Trial name
- NCT00091975
- Testing
- Zemplar Capsule
- Where
- 16 sites in United States
- Volunteers
- 78 people
- Sponsor
- Abbott
Secondary Hyperparathyroidism
Observational Program of Zemplar in Patients With End Stage Chronic Kidney Disease and Parathyroid Disorder on Hemodialysis in the Russian Federation
Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Planned therapy will be six months.
- Trial name
- NCT01401478
- Where
- 13 sites in Russia
- Volunteers
- 86 people
- Sponsor
- AbbVie (prior 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, 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
Stage 5 Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)
Four Week, Pharmacodynamic/Pharmacokinetic, Efficacy, and Safety Study of Lunacalcipol (CTA018)
Open-label, pharmacodynamic, safety, pharmacokinetic and efficacy study of Lunacalcipol Injection.
- Conditions
- Stage 5 Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT), Hemodialysis (HD)
- Trial name
- 2007 (NCT01453634)
- Testing
- Lunacalcipol 180, Lunicalcipol 270
- Sponsor
- OPKO Health, Inc.
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
Kidney Failure, Chronic
Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Zemplar® (Paricalcitol Injection) in the Treatment of Patients Suffering From End-stage Renal Disease and Severe Over-reactivity of the Parathyroid Glands
This observational study will evaluate the clinical benefit of Zemplar (paricalcitol injection) in daily routine practice in end-stage renal disease patients with severe over-reactivity of parathyroid glands.
- Trial name
- NCT01273597
- Where
- 11 sites in Hungary
- Volunteers
- 60 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Chronic Kidney Disease, Dialysis
Long-term Extension Study of MCI-196
The Primary Objectives of this study are to assess the long-term efficacy of treatment with colestilan (MCI-196) (including combination therapy) and to assess the long-term safety of treatment with colestilan (MCI-196) (including…
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Paediatric
- Trial name
- NCT01814917
- Testing
- colestilan, CBPB
- Where
- United Kingdom
- Volunteers
- 6 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
Chronic Kidney Disease, Stage 5, Secondary Hyperparathyroidism
A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease
The purpose of this study is to evaluate the effects of Zemplar® Injection and Hectorol® Injection on intestinal calcium absorption in Chronic Kidney Disease Stage 5 subjects on hemodialysis.
- Trial name
- NCT00257920
- Testing
- Zemplar® injection, Hectorol® injection
- Where
- 2 sites in United States
- Volunteers
- 41 people
- Sponsor
- Abbott
Secondary Hyperparathyroidism, Chronic Kidney Disease Stage V
Study to Evaluate the Effect of Intravenous (IV) Paricalcitol (Zemplar) on Cardiac Morbidity in Patients With Chronic Kidney Disease (CKD) Stage 5 Over 2 Years
The purpose of this study was to ascertain the percentage of cardiac patients with chronic kidney disease (CKD) stage 5 treated with paricalcitol IV achieving intact parathyroid hormone (iPTH) levels in target range of Kidney…
- Conditions
- Secondary Hyperparathyroidism, Chronic Kidney Disease Stage V, Cardiac Morbidity
- Trial name
- NCT01073462
- Where
- 12 sites in Austria
- Volunteers
- 67 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
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.