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

Primary Purpose

Chronic Kidney Diseases, Hemodialysis Complication, Hyperphosphatemia

Status
Enrolling by invitation
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Cholestyramine Resin 4000 MG [Questran]
Calcium Carbonate 500 MG Oral Tablet
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring chronic kidney disease, hyperphosphatemia in chronic adult hemodialysis patients, bile acid sequestrants: cholestyramine, serum calcium level, serum phosphate level

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ain Shams university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Test group

Control group

Arm Description

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). Dosage: one sachet on 150 ml water three times daily duration : 8 weeks

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2022
Last Updated
October 10, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05577507
Brief Title
Efficacy and Safety of Cholestyramine in the Management of Hyperphosphatemia in Adult Hemodialysis Patients
Official Title
Efficacy and Safety of Cholestyramine in the Management of Hyperphosphatemia in Adult Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 30, 2023 (Anticipated)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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 Age, sex, weight, duration of ESRD and hemodialysis comorbidities. 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. Bile acid sequestrates like colestipol, colestilan and cholestyramine are pharmacologic molecules that bind to bile acids in the intestine resulting in the interruption of bile acid homeostasis and, consequently, reduction in low-density lipoprotein cholesterol levels in hypercholesterolemia. 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. The aim of the study is to evaluate the efficacy and safety of cholestyramine in the management of hyperphosphatemia 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 Age, sex, weight, duration of ESRD and hemodialysis comorbidities. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Active Comparator
Arm Description
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). Dosage: one sachet on 150 ml water three times daily duration : 8 weeks
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Group 2: Control group, 40 patients will take only the standard therapy calcium-based phosphate binder (Calcimate).
Intervention Type
Drug
Intervention Name(s)
Cholestyramine Resin 4000 MG [Questran]
Intervention Description
cholestyramine 4 gram sachets (questran) will be administered orally on 150 ml water three times daily for 8 weeks period trial
Intervention Type
Drug
Intervention Name(s)
Calcium Carbonate 500 MG Oral Tablet
Intervention Description
control group will administer standard therapy calcium carobonate as calcium based phosphate binder 500 mg three times daily within meals
Primary Outcome Measure Information:
Title
serum phosphate level
Description
measuring serum phosphate level at baseline and after 8 weeks trial period to evaluate serum phosphate reduction by cholestyramine
Time Frame
8 weeks trial period
Title
serum calcium level
Description
measuring serum calcium level at baseline and after 8 weeks trial period to evaluate serum calcium reduction by cholestyramine
Time Frame
8 weeks trial period
Title
iPTH
Description
measuring iPTH level at baseline and after 8 weeks trial period to evaluate iPTH reduction by cholestyramine
Time Frame
8 weeks trial period
Secondary Outcome Measure Information:
Title
Lipid Profile ( triglyceride level , LDL ,HDL ,Total cholesterol )
Description
measuring LDL , total cholesterol reduction after using cholestyramine for 8 weeks trial period
Time Frame
8 weeks trial period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Ain Shams university
City
Cairo
ZIP/Postal Code
11511
Country
Egypt

12. IPD Sharing Statement

Links:
URL
https://academic.oup.com/ndt/article/28/7/1874/1859270
Description
evaluation of bile acid sequestrants as colestilan as phosphate binders
URL
https://www.e-enm.org/journal/view.php?doi=10.3803/EnM.2016.31.3.476
Description
Dose of cholestyramine and frequency of administration

Learn more about this trial

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

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