Efficacy and Safety of Cholestyramine in the Management of Hyperphosphatemia in Adult Hemodialysis Patients

• Status: Enrolling by invitation
• Trial end date: 2023-05-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to evaluate the efficacy and safety of cholestyramine in the management of hyperphosphatemia in hemodialysis patients.

Colestilan is a non-metallic phosphate binder that acts as an anion-exchange resin. Colestilan itself is not absorbed after oral administration, and it is able to bind dietary phosphate within the gastrointestinal tract and thus prevent absorption of the mineral. Initial, Phase II, studies showed that it reduces serum phosphorus levels in dialysis patients with hyperphosphatemia without affecting serum calcium levels.

There are no studies conducted about the feasibility and efficacy of cholestyramine as an oral phosphate binder in hemodialysis patients. Relying on the efficacy and safety of bile acid sequestrants such as colestilan and colestipol in the management of hyperphosphatemia and hypercholesterolemia in hemodialysis patients, cholestyramine is selected to be studied in hemodialysis patients.

A total of 80 patients will be recruited and divided into 2 groups: -

Group 1: (cholestyramine 12 gram), 40 patients will take a dose of cholestyramine 4-gram sachet in 150-200 ml water or juice three times daily within meals as an add on therapy with standard therapy calcium-based phosphate binder (Calcimate).

Group 2: Control group, 40 patients will take only the standard therapy calcium-based phosphate binder (Calcimate).

Time of the trial will be two months (8 weeks trial period)

Baseline characteristics: The following data will be collected from all patients at baseline

1. Age, sex, weight, duration of ESRD and hemodialysis comorbidities.

2. Dialysis duration, serum phosphate level, serum calcium level, iPTH, BUN, Cr (mg/d L), Albumin (mg/d L), Hb (g m%), renal function test, liver function test, blood glucose level, TG, total cholesterol level, LDL-C, HDL.C.

After the end of trial, we will examine if cholestyramine has a significant efficacy on reducing serum phosphate level in adult hemodialysis patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Calcium; Calcium Carbonate; Cholestyramine Resin

Criteria

Inclusion Criteria:

• • Patients aged ≥18 years with CKD stage (4&5)

• Serum phosphate level ≥ 5.5 mg/dL

• Serum LDL-C level ≥1.82 mmol/L (70 mg/dL)

• Hemodialysis frequency 3 times per week or more.

• Hemodialysis in the last 3 months or longer.

Exclusion Criteria:

• Patients are excluded if they have a history of clinically significant gastrointestinal motility disorder, dysphagia, or swallowing disorder.

2-patients require warfarin or digoxin treatment. 3- Patients have a history of alcohol or substance abuse 4- Patients receiving calcimimetics. 5- Pregnant patients or patients planning pregnancy. 6- Patients have Triglyceride level above 300 (mg/dl)