NCT05577507

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Kidney Diseases
• Hemodialysis Complication
• Hyperphosphatemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-03-30
• Primary completion: 2023-05-30
• Completion: 2023-06-30
• First posted: 2022-10-13
• Last updated: 2024-08-06

Locations

1 site across 1 country: Egypt