A Phase 4 interventional study of Cholestyramine Resin 4000 MG [Questran] and Calcium Carbonate 500 MG Oral Tablet in Chronic Kidney Diseases, Hemodialysis Complication and Hyperphosphatemia, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment
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
After the end of trial, we will examine if cholestyramine has a significant efficacy on reducing serum phosphate level in adult hemodialysis patients.
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
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
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's enrollment of 80 is close to the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Patients aged ≥18 years with CKD stage (4\&5)
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)
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
Group 2: Control group, 40 patients will take only (Calcimate).
Drug: Calcium Carbonate 500 MG Oral Tablet
cholestyramine 4 gram sachets (questran) will be administered orally three times daily for 8 weeks period trial
control group will administer standard therapy calcimate 500 mg three times daily within meals
serum phosphate level
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
serum calcium level
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
iPTH
measuring iPTH level at baseline and after 8 weeks trial period to evaluate iPTH reduction by cholestyramine
Time frame: 8 weeks trial period
Lipid Profile ( triglyceride level , LDL ,HDL ,Total cholesterol )
measuring LDL , total cholesterol reduction after using cholestyramine for 8 weeks trial period
Time frame: 8 weeks trial period
Ran from Mar 2023 to primary completion in May 2023, 2 months.
Of 100 non-industry phase 4 interventional studies under Renal Insufficiency, Chronic, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 67. This study's 2 months is below that.
Counting every sponsor, half of 116 studies reached it within 43 months; a quarter within 22 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholestyramine Resin
Renal Insufficiency, Chronic →