Hyperphosphatemia Clinical Trial
Official title:
The Efficacy and Safety of Nicotinic Acid in the Hemodialysis Patients With Hyperphosphatemia
With calcium carbonate as the positive control drug, to observe the effectiveness and safety of nicotinic acid in hemodialysis patients with hyperphosphatemia
Hyperphosphatemia is an important risk factor affecting long-term survival in patients with hemodialysis. Nicotinic acids, as well as its metabolites nicotinamide, were found to inhibit the sodium-phosphorus co-transporter on animal intestines. Several studies from other countries demonstrated that nicotinamide can reduce blood phosphorus levels in end-stage kidney disease patients. The purpose of this study was to investigate the effectiveness and safety of nicotinic acids on hyperphosphatemia in hemodialysis patients of ethnic Han live in China. The study is a prospective, randomized, double-blind, placebo-controlled crossover study. Eligible patients will be randomized to 6 wk of nicotinic acids or calcium carbonate. After a 2-wk washout period, patients switched to 6 wk of the alternative therapy. The primary measurement is the change in serum phosphorus during the whole term of each arm. Statistical analysis will be performed using two-sample paired-group t test.The significance level of the analysis was set to 0.05. All other adverse reactions will be analysed and reported, if there. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT02237534 -
Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia
|
Phase 4 | |
| Unknown status |
NCT01245517 -
The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient
|
N/A | |
| Completed |
NCT01187628 -
Long-term Study in Chronic Kidney Disease (Extension From Study 14817)
|
Phase 3 | |
| Completed |
NCT01252771 -
Phosphate Kinetic Modeling 2
|
Phase 4 | |
| Completed |
NCT00506441 -
A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia
|
Phase 3 | |
| Recruiting |
NCT04440696 -
To Evaluate the Patient Tolerance, Pharmacodynamics and Pharmacokinetics of Lanthanum Polystyrene Sulfonate Powder
|
Phase 1/Phase 2 | |
| Completed |
NCT01976572 -
Drug-Drug Interaction Study to Evaluate the Effect of Colestilan on the Pharmacokinetics of Single Doses of Candesartan Cilexetil in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01742585 -
A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis
|
Phase 3 | |
| Completed |
NCT01191255 -
A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
|
Phase 3 | |
| Completed |
NCT01003223 -
Phosphate Kinetic Modeling
|
N/A | |
| Completed |
NCT00505037 -
A Phase 2 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis
|
Phase 2 | |
| Completed |
NCT00508885 -
The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients
|
Phase 1/Phase 2 | |
| Completed |
NCT04551300 -
A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients
|
Phase 2 | |
| Completed |
NCT01955876 -
Fosrenol Post-marketing Surveillance in Japan
|
N/A | |
| Completed |
NCT04579315 -
Long-term Effects of the New Nordic Renal Diet in Patients With Moderate Chronic Kidney Disease
|
N/A | |
| Completed |
NCT03861247 -
Individualized Treatment of Hyperphosphatemia in Maintenance Hemodialysis Patients
|
Phase 3 | |
| Terminated |
NCT01725113 -
Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol
|
Phase 4 | |
| Recruiting |
NCT01238588 -
The Effect(s) of Sevelamer Carbonate (Renvela) on Atherosclerotic Plaque Inflammation Judged by FDG-PET Scan
|
N/A | |
| Completed |
NCT00542815 -
A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
|
Phase 3 | |
| Completed |
NCT04549597 -
Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia
|
Phase 4 |