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

NCT05577507 | Completed Phase 4

• 1 other identifier: RHDIRB2020110301 REC#102
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 1.Age, sex, weight, duration of ESRD and hemodialysis comorbidities.
2. 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.

Conditions

Chronic Kidney Diseases; Hemodialysis Complication; Hyperphosphatemia

Keywords

chronic kidney disease; hyperphosphatemia in chronic adult hemodialysis patients; bile acid sequestrants: cholestyramine; serum calcium level, serum phosphate level

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Lipid Profile ( triglyceride level , LDL ,HDL ,Total cholesterol )

  8 weeks trial period

Study Arms (2)

Test group

ACTIVE COMPARATOR

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]; Drug: Calcium Carbonate 500 MG Oral Tablet

Control group

PLACEBO COMPARATOR

Group 2: Control group, 40 patients will take only (Calcimate).

Drug: Calcium Carbonate 500 MG Oral Tablet

Interventions

Cholestyramine Resin 4000 MG [Questran] DRUG

cholestyramine 4 gram sachets (questran) will be administered orally three times daily for 8 weeks period trial

Test group

Calcium Carbonate 500 MG Oral Tablet DRUG

control group will administer standard therapy calcimate 500 mg three times daily within meals

Control group; Test group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients are excluded if they have a history of dysphagia, or swallowing disorder.
• 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)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university

Cairo, 11511, Egypt

Location

Related Publications (1)

• Ghanem AEAEHA, Borolossy RME, Said TWE, Shaheen SMZ. Cholestyramine in hemodialysis: a new approach for hyperphosphatemia management. Korean J Physiol Pharmacol. 2025 Jul 1;29(4):465-473. doi: 10.4196/kjpp.24.269. Epub 2025 Feb 6.

  PMID: 39910709 DERIVED

Related Links

• Dose of cholestyramine and frequency of administration

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperphosphatemia

Interventions

Cholestyramine Resin; Calcium Carbonate; Tablets

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Polystyrenes; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator at clinical pharmacy department , Sinai university

Model Details: 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 three times daily with standard therapy(Calcimate). Group 2: Control group, 40 patients will take only the standard therapy (Calcimate). Time of the trial will be two months (8 weeks trial period)

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: March 30, 2023
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

EG (1)