Chronic Kidney DiseasesPhase 4NCT05577507
Efficacy and Safety of Cholestyramine in the Management of Hyperphosphatemia in Adult Hemodialysis Patients
A Phase 4 study testing Cholestyramine Resin 4000 MG [Questran] and Calcium Carbonate 500 MG Oral Tablet in people with Chronic Kidney Diseases and Hemodialysis Complication, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Diseases, Hemodialysis Complication, Hyperphosphatemia
- What is being tested?
- Cholestyramine Resin 4000 MG [Questran] and Calcium Carbonate 500 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2023to 30 Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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)
Read more
Baseline characteristics: The following data will be collected from all patients at baseline
- Age, sex, weight, duration of ESRD and hemodialysis comorbidities.
- 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.
Read the 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
- Age, sex, weight, duration of ESRD and hemodialysis comorbidities.
- 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
- Being tested
- Cholestyramine Resin 4000 MG [Questran], Calcium Carbonate 500 MG Oral Tablet
- Keywords
- chronic kidney disease, hyperphosphatemia in chronic adult hemodialysis patients, bile acid sequestrants: cholestyramine, serum calcium level, serum phosphate level
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholestyramine Resin 4000 MG [Questran]Drug
cholestyramine 4 gram sachets (questran) will be administered orally three times daily for 8 weeks period trial
Calcium Carbonate 500 MG Oral TabletDrug
control group will administer standard therapy calcimate 500 mg three times daily within meals
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Cholestyramine Resin 4000 MG [Questran]; Drug: Calcium Carbonate 500 MG Oral Tablet |
| Control group | Placebo comparator | Group 2: Control group, 40 patients will take only (Calcimate). Receives: Drug: Calcium Carbonate 500 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum phosphate level
measuring serum phosphate level at baseline and after 8 weeks trial period to evaluate serum phosphate reduction by cholestyramine
Measured: 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
Measured: 8 weeks trial period
iPTH
measuring iPTH level at baseline and after 8 weeks trial period to evaluate iPTH reduction by cholestyramine
Measured: 8 weeks trial period
Secondary outcomes (1)
Lipid Profile ( triglyceride level , LDL ,HDL ,Total cholesterol )
measuring LDL , total cholesterol reduction after using cholestyramine for 8 weeks trial period
Measured: 8 weeks trial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start30 Mar 2023
- Primary completion30 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Essam Aly, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577507
- Sponsor's protocol ID
- RHDIRB2020110301 REC#102
- Status last verified
- Aug 2024
- First submitted
- 10 Oct 2022
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39910709
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cholestyramine in the Management of Hyperphosphatemia in Adult Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05577507
- Acronym / sponsor ID
- RHDIRB2020110301 REC#102
- Keywords
- chronic kidney disease, hyperphosphatemia in chronic adult hemodialysis patients, bile acid sequestrants: cholestyramine, serum calcium level, serum phosphate level
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Age, sex, weight, duration of ESRD and hemodialysis comorbidities.
- 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
- Age, sex, weight, duration of ESRD and hemodialysis comorbidities.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Test group | Active comparator | Drug: Cholestyramine Resin 4000 MG [Questran], Drug: Calcium Carbonate 500 MG Oral TabletGroup 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 | Drug: Calcium Carbonate 500 MG Oral TabletGroup 2: Control group, 40 patients will take only (Calcimate). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Patients aged ≥18 years with CKD stage (4\&5)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cholestyramine Resin 4000 MG [Questran]cholestyramine 4 gram sachets (questran) will be administered orally three times daily for 8 weeks period trial | Drug | Test group |
| Calcium Carbonate 500 MG Oral Tabletcontrol group will administer standard therapy calcimate 500 mg three times daily within meals | Drug | Control group, Test group |
Primary outcome
serum phosphate level
Time frame: 8 weeks trial period
measuring serum phosphate level at baseline and after 8 weeks trial period to evaluate serum phosphate reduction by cholestyramine
serum calcium level
Time frame: 8 weeks trial period
measuring serum calcium level at baseline and after 8 weeks trial period to evaluate serum calcium reduction by cholestyramine
iPTH
Time frame: 8 weeks trial period
measuring iPTH level at baseline and after 8 weeks trial period to evaluate iPTH reduction by cholestyramine
1 secondary outcome
Lipid Profile ( triglyceride level , LDL ,HDL ,Total cholesterol )
Time frame: 8 weeks trial period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Derived from this study: PubMed 39910709Ghanem 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.
- Dose of cholestyramine and frequency of administrationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cholestyramine Resin 4000 MG [Questran] and Calcium Carbonate 500 MG Oral Tablet in people with Chronic Kidney Diseases and Hemodialysis Complication, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum phosphate level (time frame: 8 weeks trial period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05577507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.