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

Phase 4

Completed

• Conditions: Chronic Kidney Diseases; Hemodialysis Complication; Hyperphosphatemia
• Interventions: Drug: Cholestyramine Resin 4000 MG [Questran]; Drug: Calcium Carbonate 500 MG Oral Tablet

• Registration Number: NCT05577507
• Lead Sponsor: Ain Shams University

Brief Summary

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

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.

Detailed Description

Chronic kidney disease-mineral and bone disorder (CKD-MBD) is characterized by progressive loss of renal function as well as dysregulation of mineral and bone metabolism, leading frequently to hyperphosphatemia.

Multiple studies have consistently shown that hyperphosphatemia is associated with cardiovascular events and increased morbidity and mortality in end-stage renal disease (ESRD) patients.

Importantly, use of phosphate binding agents and reduction of serum phosphate concentration are associated with a lower risk of mortality.

The most widely used phosphate binders are calcium-based, although they are frequently associated with hypercalcemia and vascular calcification.

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.

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

Group 1: 40 patients will take a dose of cholestyramine 4-gram sachet three times daily with standard therapy (Calcimate).

Group 2: 40 patients will take only the standard therapy (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.

Parameters will be collected from all patients after 8-week trial period: Serum phosphate, serum calcium, iPTH, LDL, TG and total cholesterol level

Study Timeline

• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-10
• Study First Posted: 2022-10-13
• Study Start: 2023-03-30
• Primary Completion: 2023-05-30
• Study Completion: 2023-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 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. 6- Patients have Triglyceride level above 300 (mg/dl)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Calcium Carbonate 500 MG Oral Tablet	Group 1: (cholestyramine 12 gram), 40 patients will take a dose of cholestyramine 4-gram sachets three times daily within meals with (Calcimate). Dosage: one sachet on 150 ml water three times daily duration : 8 weeks
Test group	Cholestyramine Resin 4000 MG [Questran]	Group 1: (cholestyramine 12 gram), 40 patients will take a dose of cholestyramine 4-gram sachets three times daily within meals with (Calcimate). Dosage: one sachet on 150 ml water three times daily duration : 8 weeks
Control group	Calcium Carbonate 500 MG Oral Tablet	Group 2: Control group, 40 patients will take only (Calcimate).

Primary Outcome Measures

Name	Time	Method
serum phosphate level	8 weeks trial period	measuring serum phosphate level at baseline and after 8 weeks trial period to evaluate serum phosphate reduction by cholestyramine
serum calcium level	8 weeks trial period	measuring serum calcium level at baseline and after 8 weeks trial period to evaluate serum calcium reduction by cholestyramine
iPTH	8 weeks trial period	measuring iPTH level at baseline and after 8 weeks trial period to evaluate iPTH reduction by cholestyramine

Secondary Outcome Measures

Name	Time	Method
Lipid Profile ( triglyceride level , LDL ,HDL ,Total cholesterol )	8 weeks trial period	measuring LDL , total cholesterol reduction after using cholestyramine for 8 weeks trial period

Trial Locations

Locations (1)

Ain Shams university; 🇪🇬 Cairo, Egypt