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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Active Comparator | 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 |
|
| Control group | Placebo Comparator | Group 2: Control group, 40 patients will take only (Calcimate). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholestyramine Resin 4000 MG [Questran] | Drug | cholestyramine 4 gram sachets (questran) will be administered orally three times daily for 8 weeks period trial |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum phosphate level | measuring serum phosphate level at baseline and after 8 weeks trial period to evaluate serum phosphate reduction by cholestyramine | 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 | 8 weeks trial period |
| iPTH | measuring iPTH level at baseline and after 8 weeks trial period to evaluate iPTH reduction by cholestyramine | 8 weeks trial period |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid Profile ( triglyceride level , LDL ,HDL ,Total cholesterol ) | measuring LDL , total cholesterol reduction after using cholestyramine for 8 weeks trial period | 8 weeks trial period |
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Inclusion Criteria:
• 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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams university | Cairo | 11511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39910709 | Derived | Ghanem AEAEHA, Borolossy RME, Said TWE, Shaheen SMZ. Cholestyramine in hemodialysis: a new approach for hyperphosphatemia management. Korean J Physiol Pharmacol. 2025 Jul 1;29(4):465-473. doi: 10.4196/kjpp.24.269. Epub 2025 Feb 6. |
| Label | URL |
|---|---|
| Dose of cholestyramine and frequency of administration | View source |
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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)
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| Calcium Carbonate 500 MG Oral Tablet | Drug | control group will administer standard therapy calcimate 500 mg three times daily within meals |
|
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002792 | Cholestyramine Resin |
| D002119 | Calcium Carbonate |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D011137 | Polystyrenes |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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