Clinical trials: Chronic Kidney Disease Stage V
Chronic Kidney Disease, Dialysis
A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia
This study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks treatment period by MCI-196 or placebo, (both on Ca based phosphate binder).
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- Trial name
- NCT00451295
- Testing
- MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)
- Where
- 25 sites in Czechia, France and 8 more
- Volunteers
- 6 people
- Sponsor
- Tanabe Pharma Corporation
Secondary Hyperparathyroidism Due to Renal Causes, Chronic Kidney Diseases
Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
Safety, Efficacy, PK and PD of CTAP101 (calcifediol) ER Capsules for SHPT in HD Patients VDI
- Conditions
- Secondary Hyperparathyroidism Due to Renal Causes, Chronic Kidney Diseases, Vitamin D Deficiency, Stage 5 Chronic Kidney Disease
- Trial name
- NCT03602261
- Testing
- Calcifediol Oral Capsule
- Where
- 18 sites in United States
- Volunteers
- 44 people
- Sponsor
- OPKO Health, Inc.
Chronic Kidney Disease Stage 5
Quality of Life and Depression in Dialysis Patients
The aim of this study is to evaluate quality of life (QOL) and depression in peritoneal dialysis patients compare to hemodialysis patients and assess hydration effect on QOL and depression over time.
- Trial name
- QOLD (NCT01668628)
- Where
- South Korea
- Volunteers
- 1,068 people
- Sponsor
- Fresenius Medical Care Korea
Secondary Hyperparathyroidism
A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection
Protocol HECT00306 aims to determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting from Zemplar (paricalcitol injection) for the treatment of secondary hyperparathyroidism in Stage 5 chronic…
- Trial name
- NCT00463021
- Testing
- Hectorol (doxercalciferol capsules), Zemplar (paricalcitol injection)
- Where
- 8 sites in United States
- Volunteers
- 36 people
- Sponsor
- Genzyme, a Sanofi Company
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, Secondary Hyperparathyroidism
Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D
Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.
- Conditions
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Hemodialysis
- Trial name
- IMPACT SHPT (NCT00977080)
- Testing
- Paricalcitol, Cinacalcet
- Where
- 83 sites in United States, Czechia and 10 more
- Volunteers
- 272 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)
Anemia of Chronic Kidney Disease
Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients
Phase III, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of Megalabs® recombinant human alfa epoetin for intravenous use, compared to Epogen®, in…
- Trial name
- ENCASE (NCT06352138)
- Testing
- Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration., Active comparator: European Union licenced epoetin alfa
- Where
- Uruguay
- Volunteers
- 280 people
- Sponsor
- Megalabs
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)
Hyperphosphatemia, Chronic Kidney Disease
Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects
The primary objective is to assess the effects of colestilan on the pharmacokinetic profile of candesartan cilexetil when administered at the same time as, 1 hour before, and 3 hours after the first daily dose of colestilan…
- Trial name
- NCT01976572
- Testing
- colestilan, candesartan
- Where
- United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
Anemia
An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Stage V Chronic Kidney Disease Participants on Hemodialysis
This observational study will evaluate the efficacy and use of Methoxy polyethylene glycol-epoetin beta (Mircera) in participants with Stage V chronic kidney disease on hemodialysis receiving an erythropoietin prior to study…
- Trial name
- NCT01940484
- Testing
- Methoxy polyethylene glycol epoetin beta
- Where
- 10 sites in South Africa
- Volunteers
- 98 people
- Sponsor
- Hoffmann-La Roche
Hypertensive Nephropathy, Auto Immune Disorders
ACE Reno, Pico Cell Matrix and Its Effect on eGFR in Chronic Kidney Diseases
This study investigates the safety and efficacy of ACE Reno, an oral transmucosal solution containing standardized bioactive peptides and amino acids, in patients with nephropathy of various etiologies and stages.
- Conditions
- Hypertensive Nephropathy, Auto Immune Disorders, Chronic Kidney Disease, Chronc Kidney Disease Stage 5
- Trial name
- ACE Reno (NCT07187713)
- Testing
- ACE Reno
- Where
- Egypt
- Volunteers
- 300 people
- Sponsor
- Ace Cells Lab Limited
Chronic Kidney Disease, Dialysis
A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- Trial name
- NCT00542815
- Testing
- MCI-196, Another Phosphate binder (Sevelamer)
- Where
- 115 sites in Austria, Czechia and 13 more
- Volunteers
- 632 people
- Sponsor
- Tanabe Pharma Corporation
Chronic Kidney Disease
Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered as Single Bolus Injections in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)
The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 100 mg, 200 mg or 500 mg in subjects with Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).
- Trial name
- NCT01469078
- Testing
- Monofer®
- Volunteers
- 18 people
- Sponsor
- Pharmacosmos A/S
Chronic Kidney Disease, Dialysis
A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia
This is a phase III multi-centre study in two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Dyslipidemia
- Trial name
- NCT00542386
- Testing
- MCI-196
- Where
- 73 sites in Hungary, Italy and 6 more
- Volunteers
- 642 people
- Sponsor
- Tanabe Pharma Corporation
Chronic Kidney Disease, Stage 5
Head to Head Study Against Sevelamer Hydrochloride
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
- Trial name
- NCT00441545
- Testing
- Fosrenol (Lanthanum Carbonate), Sevelamer hydrochloride
- Where
- 44 sites in United States, Germany and 2 more
- Volunteers
- 182 people
- Sponsor
- Shire
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
Moderate to Severe Secondary Hyperparathyroidism, Stage 5 Chronic Kidney Diseases
A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients
To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant patients with stage 5 chronic kidney disease.
- Trial name
- NCT01506947
- Testing
- Paricalcitol, Darbepoetin alfa
- Volunteers
- 65 people
- Sponsor
- AbbVie (prior sponsor, Abbott)