Clinical trial NCT05577507: 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
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 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 purpose: TREATMENT

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. 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

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 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)

Primary outcomes:
measure: serum phosphate level
timeFrame: 8 weeks trial period
measure: serum calcium level
timeFrame: 8 weeks trial period
measure: iPTH
timeFrame: 8 weeks trial period
Secondary outcomes:
measure: Lipid Profile ( triglyceride level , LDL ,HDL ,Total cholesterol )
timeFrame: 8 weeks trial period
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university
Study officials:
References: