Clinical Trials Logo

Clinical Trial Summary

Hyperphosphatemia is common in the peritoneal dialysis population. Current strategies are insufficient to optimize phosphorus control. Animal studies have shown niacinamide, a form of vitamin B, to reduce phosphate uptake by the rat small intestine. Our trial investigates the use of niacinamide, in addition to standard phosphorus lowering strategies, to reduce plasma phosphorus levels in peritoneal dialysis patients versus placebo.


Clinical Trial Description

This is a prospective, randomized, double-blind, placebo-controlled 8-week clinical trial to evaluate the efficacy of niacinamide versus placebo to reduce plasma phosphorus levels in peritoneal dialysis patients. Patients on a stable regimen of phosphate binders with plasma phosphorus levels > 4.9 mg/dL are eligible for enrollment and randomization. The study will span 8 weeks of active medication treatment. The primary end-point will be absolute change in plasma phosphorus levels. Sixteen patients (8 randomized to each treatment arm) are needed to detect a 1.5 mg/dL difference assuming a standard deviation of 1 and powered at 80% (alpha 0.05). Placebo will be packaged to resemble the study drug in all physical attributes. The starting dose of niacinamide will be 250 mg twice daily to be titrated to 500 mg twice daily at the end of week 2 with a final titration to 750 mg twice daily at the end of week 4. Secondary end-points will include absolute change in the calcium-phosphorus product, intact parathyroid hormone, hemoglobin, platelet count, total cholesterol, HDL cholesterol, and percentage change in plasma phosphorus. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00508885
Study type Interventional
Source Washington University School of Medicine
Contact
Status Completed
Phase Phase 1/Phase 2
Start date October 2006
Completion date July 2007

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT02237534 - Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia Phase 4
Completed NCT01187628 - Long-term Study in Chronic Kidney Disease (Extension From Study 14817) Phase 3
Completed NCT01252771 - Phosphate Kinetic Modeling 2 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 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 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
Active, not recruiting 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
Completed NCT04789876 - Effectiveness of The Phosphate Mobile App on Serum Phosphorus in Adult Hemodialysis Patients With Hyperphosphatemia N/A