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Hyperphosphatemia clinical trials

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NCT ID: NCT01252771 Completed - Hyperphosphatemia Clinical Trials

Phosphate Kinetic Modeling 2

PKM2
Start date: September 2010
Phase: Phase 4
Study type: Interventional

The study aims to investigate the concept of computer based Phosphate Kinetic Modeling (PKM) in the hemodialysis patient population. This computerized algorithm model was developed as a tool to aid physicians in controlling a hemodialysis patient's phosphate level. Once a subject consents to participate in the study, the subject's dietary phosphate intake will be estimated by the modeling program and the appropriate dose of the phosphate binder calcium acetate (PhosLo) will be recommended accordingly. If necessary, the Ca++ concentration of the dialysate will be changed to remove any excess calcium absorbed as the result of an increase in the PhosLo prescription to control phosphorus.

NCT ID: NCT01200784 Completed - Clinical trials for Chronic Kidney Disease

Nicotinamide in Hemodialysis Patients With Hyperphosphatemia

DONATO
Start date: August 2010
Phase: Phase 2
Study type: Interventional

Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum phosphate levels of dialysis patients in a dose dependent manner.

NCT ID: NCT01191255 Completed - Kidney Failure Clinical Trials

A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis

Start date: October 2010
Phase: Phase 3
Study type: Interventional

This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.

NCT ID: NCT01187628 Completed - Hyperphosphatemia Clinical Trials

Long-term Study in Chronic Kidney Disease (Extension From Study 14817)

Start date: September 2010
Phase: Phase 3
Study type: Interventional

The objective of this study is to investigate the safety and the effect on reduction of serum phosphate of long-term administration of lanthanum carbonate (BAY77-1931) 750 to 2250 mg in patients with hyperphosphatemia who completed the 8 week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study.

NCT ID: NCT01110629 Completed - Hyperphosphatemia Clinical Trials

Study in Chronic Kidney Disease (CKD) Not on Dialysis

Start date: June 2010
Phase: Phase 3
Study type: Interventional

The objective of this study is to investigate the efficacy and safety of lanthanum carbonate 750 to 2,250 mg in Japanese Chronic Kidney Disease Stage 3, 4 and 5 subjects not on dialysis.

NCT ID: NCT01074125 Completed - Clinical trials for End-Stage Renal Disease

A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease

Start date: May 2010
Phase: Phase 3
Study type: Interventional

This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in small amounts. Patients with kidney failure have trouble getting rid of the phosphorus eaten in food. Dialysis can help remove some of the phosphorus, but often patients must take a phosphate binder like PhosLo®, Renagel®, or Renvela® to bring the blood phosphorus levels back to normal. The purpose of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a phosphate binder.

NCT ID: NCT01069692 Completed - Clinical trials for Chronic Kidney Disease

Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients

SBR759
Start date: February 2010
Phase: Phase 3
Study type: Interventional

This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.

NCT ID: NCT01057407 Completed - Clinical trials for Chronic Kidney Disease

A Comparative Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis

Start date: January 2010
Phase: Phase 3
Study type: Interventional

This is a multi-center, open-labeled study to examine the non-inferiority of ASP1585 to sevelamer hydrochloride in chronic kidney disease patients with hyperphosphatemia on hemodialysis.

NCT ID: NCT01057108 Completed - Clinical trials for Chronic Kidney Disease

Double Blind Randomized Placebo Controlled Trial of FOSTRAP Chewing Gum in Patients With CKD and Hyperphosphatemia

Start date: January 2010
Phase: Phase 1
Study type: Interventional

The phosphorus content in saliva is increased in chronic kidney disease. We hypothesize that a chewing gum that binds salivary phosphorus would be a novel, effective agent to reduce serum levels of phosphorus in patients with chronic kidney disease. We are testing this hypothesis using a chewing gum called FOSTRAP which has been shown to be effective in a small, non-randomized study in patients with chronic kidney disease on hemodialysis.

NCT ID: NCT01053676 Completed - Hyperphosphatemia Clinical Trials

Bioequivalence Study of BAY77-1931 Granule

Start date: January 2010
Phase: Phase 1
Study type: Interventional

The study is conducted as a randomized, non-blinded, 2-way crossover study. Target population is 60 Japanese healthy male adult subjects selected by screening examination which will be conducted within 4 weeks before the first drug administration of period 1 (before the hospitalization of period 1). Subjects will admit in the clinical institute on Day -3 and be discharged on Day 6 in each period. During hospitalization, standardized phosphate diet from Day -2 to Day 4 will start approximately 20 minutes before dosing. Subject will take about 1300 mg of phosphate evenly at breakfast lunch and dinner for each day. Subject should consume at least 95% of a meal. Distilled water not to include phosphate will be used for drinking water and meal. Subjects are to drink at least 1 L of distilled water every day in clinic to make sure enough urine volume. The 24 hours urine collection will be conducted between Day -2 and Day 4 to investigate the urinary phosphate excretion.BAY77-1931 granule 500 mg or Fosrenol chewable tablet 500 mg will be administered three times daily after each meal from Day 1 to Day 4. On day 4 single dose after breakfast will be administered. Study drugs will be administered immediately after each meal, that is within 20 minutes after start of each meal with 240 mL of distilled water. A Fosrenol chewable tablet 500 mg will be taken after chewing completely.