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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-30

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Chronic Kidney Diseases Hemodialysis Complication Hyperphosphatemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Cholestyramine Resin 4000 MG [Questran]

Intervention Type DRUG

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

Calcium Carbonate 500 MG Oral Tablet

Intervention Type DRUG

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

Control group

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

Group Type PLACEBO_COMPARATOR

Calcium Carbonate 500 MG Oral Tablet

Intervention Type DRUG

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

Interventions

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Cholestyramine Resin 4000 MG [Questran]

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

Intervention Type DRUG

Calcium Carbonate 500 MG Oral Tablet

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No