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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Hemodialysis Complication; Hyperphosphatemia
• Intervention / Treatment: Drug: Cholestyramine Resin 4000 MG [Questran]; Drug: Calcium Carbonate 500 MG Oral Tablet

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11511
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Test group; 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	Drug: Cholestyramine Resin 4000 MG [Questran]; cholestyramine 4 gram sachets (questran) will be administered orally three times daily for 8 weeks period trial; Drug: Calcium Carbonate 500 MG Oral Tablet; control group will administer standard therapy calcimate 500 mg three times daily within meals
Placebo Comparator: Control group; Group 2: Control group, 40 patients will take only (Calcimate).	Drug: Calcium Carbonate 500 MG Oral Tablet; control group will administer standard therapy calcimate 500 mg three times daily within meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum phosphate level	measuring serum phosphate level at baseline and after 8 weeks trial period to evaluate serum phosphate reduction by cholestyramine	8 weeks trial period
serum calcium level	measuring serum calcium level at baseline and after 8 weeks trial period to evaluate serum calcium reduction by cholestyramine	8 weeks trial period
iPTH	measuring iPTH level at baseline and after 8 weeks trial period to evaluate iPTH reduction by cholestyramine	8 weeks trial period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid Profile ( triglyceride level , LDL ,HDL ,Total cholesterol )	measuring LDL , total cholesterol reduction after using cholestyramine for 8 weeks trial period	8 weeks trial period

Collaborators and Investigators

• Sponsor: Ain Shams University

Publications and helpful links

Helpful Links

• evaluation of bile acid sequestrants as colestilan as phosphate binders
• Dose of cholestyramine and frequency of administration

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: chronic kidney disease; hyperphosphatemia in chronic adult hemodialysis patients; bile acid sequestrants: cholestyramine; serum calcium level, serum phosphate level
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Phosphorus Metabolism Disorders; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Calcium-Regulating Hormones and Agents; Antacids; Calcium; Calcium Carbonate; Cholestyramine Resin
• Other Study ID Numbers: RHDIRB2020110301 REC#102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No