Kidney Failure, ChronicSIRNCT00837655
Effect of Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure (CKD)
A study testing Sevelamer and Calcium carbonate in people with Kidney Failure, Chronic and End-Stage Renal Disease, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
The purpose of this study is to perform a randomized, controlled clinical trial to investigate if the phosphate binder sevelamer can improve insulin resistance and glucose handling in patients receiving maintenance hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Failure, Chronic, End-Stage Renal Disease, Insulin Resistance
- What is being tested?
- Sevelamer and Calcium carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2009to Jun 2011
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients 18-80 years of age with chronic renal failure treated with maintenance HD for >3 months.
Who cannot join
- Diabetes mellitus
- Treatment with sevelamer within 3 months prior to enrollment
- Acute, clinically significant inflammation within 1 month prior to enrollment
- Pregnancy or breast-feeding
- Clinically significant obstipation or bowel obstruction
- Discontinuation of previous sevelamer treatment because of side effects
Show all 10Show fewer
- Expected time in HD < 1 year
- Unwillingness to undergo the investigations and follow-up required in the the protocol
- Patients who have received any investigational drug within 1 month prior to enrolment
- Participation in another study, which may interfere with the present study
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Sahlgrenska University Hospital
Gothenburg, Gothenburg, 413 45
Karolinska University Hospital
Stockholm, Stockholm County, 14186
About this study
Official title: Study of the Effect of Treatment With Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure
The purpose of this study is to perform a randomized, controlled clinical trial to investigate if the phosphate binder sevelamer can improve insulin resistance and glucose handling in patients receiving maintenance hemodialysis.
- Being tested
- Sevelamer, Calcium carbonate
- Keywords
- Chronic kidney disease, End-stage renal disease, phosphate binder, insulin resistance, glucose intolerance, sevelamer
- Medical subject headings
- Kidney Failure, Chronic, Insulin Resistance, Hyperphosphatemia, Renal Insufficiency, Chronic, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevelamerDrug
Also called Renagel
sevelamer tablets, 800 mg (Renagel(r), Genzyme Inc). The initial daily dose of sevelamer will be 2400 mg (800 mg x 3). After the first week of treatment the dose will be increased to 4800 mg. If treatment with sevelamer is well tolerated and if a phosphate concentration of <1.8 mmol/l is not obtained, the dose may be increased further. The maximum daily dose of sevelamer will be 9600 mg. If a patient experiences side effects, the dose of sevelamer will be reduced to the highest acceptable dose, and, if a phosphate concentration of <1.8 mmol/l is not obtained, the treatment will be supplemented with calcium carbonate in a dose tolerated by the patient.
Calcium carbonateDrug
Calcium carbonate tablets, 250 mg (Kalcidon, Abigo AB). Calcium carbonate will be prescribed at the dose given prior to the washout period. The dose will be adjusted weekly to obtain a serum phosphate concentration <1.8 mmol/l.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sevelamer intervention Receives: Drug: Sevelamer |
| 2 | Active comparator | Calcium carbonate Receives: Drug: Calcium carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity and/or glucose tolerance from baseline to the end of the study, as obtained by ISIOGTT.
Measured: Week 12
Secondary outcomes (4)
Change from baseline to the end of the trial in surrogate markers of phosphate balance (PTH, s-urea, s-creatinine, ionized Ca, phosphate).
Measured: Week 12
Change from baseline to end of the study in markers of lipid homeostasis (total cholesterol, LDL, HDL, ApoA, ApoB, TG, free fatty acids)
Measured: Week 12
Change from baseline to the end of the study in circulating inflammatory cytokines (hsCRP, TNF, fibrinogen, PAI, fetuin)
Measured: Week 12
Number of adverse events directly attributable to sevelamer or calciumcarbonate treatments.
Measured: Weekly until end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: PI retired
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 Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Investigators
- Anders Alvestrand, MD PhD, Principal investigator, Karolinska InstitutetJonas Axelsson, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837655
- Sponsor's protocol ID
- SIR_CT_CLINTEC_01
- Acronym
- SIR
- Status last verified
- Jan 2009
- First submitted
- 29 Jan 2009
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Soonthornpun S, Setasuban W, Thamprasit A, Chayanunnukul W, Rattarasarn C, Geater A. Novel insulin sensitivity index derived from oral glucose tolerance test. J Clin Endocrinol Metab. 2003 Mar;88(3):1019-23. doi: 10.1210/jc.2002-021127.
PubMed 12629079
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Treatment With Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT00837655
- Acronym / sponsor ID
- SIR / SIR_CT_CLINTEC_01
- Keywords
- Chronic kidney disease, End-stage renal disease, phosphate binder, insulin resistance, glucose intolerance, sevelamer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI retired
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- Jan 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 5 Feb 2009 (estimated)
- 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.
The purpose of this study is to perform a randomized, controlled clinical trial to investigate if the phosphate binder sevelamer can improve insulin resistance and glucose handling in patients receiving maintenance hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SevelamerSevelamer intervention |
| 2 | Active comparator | Drug: Calcium carbonateCalcium carbonate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female patients 18-80 years of age with chronic renal failure treated with maintenance HD for >3 months.
Key exclusion criteria (10 listed)
- Diabetes mellitus
- Treatment with sevelamer within 3 months prior to enrollment
- Acute, clinically significant inflammation within 1 month prior to enrollment
- Pregnancy or breast-feeding
- Clinically significant obstipation or bowel obstruction
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 |
|---|---|---|
| SevelamerAlso: Renagelsevelamer tablets, 800 mg (Renagel(r), Genzyme Inc). The initial daily dose of sevelamer will be 2400 mg (800 mg x 3). After the first week of treatment the dose will be increased to 4800 mg. If treatment with sevelamer is well tolerated and if a phosphate concentration of <1.8 mmol/l is not obtained, the dose may be increased further. The maximum daily dose of sevelamer will be 9600 mg. If a patient experiences side effects, the dose of sevelamer will be reduced to the highest acceptable dose, and, if a phosphate concentration of <1.8 mmol/l is not obtained, the treatment will be supplemented with calcium carbonate in a dose tolerated by the patient. | Drug | 1 |
| Calcium carbonateCalcium carbonate tablets, 250 mg (Kalcidon, Abigo AB). Calcium carbonate will be prescribed at the dose given prior to the washout period. The dose will be adjusted weekly to obtain a serum phosphate concentration <1.8 mmol/l. | Drug | 2 |
Primary outcome
Change in insulin sensitivity and/or glucose tolerance from baseline to the end of the study, as obtained by ISIOGTT.
Time frame: Week 12
4 secondary outcomes
Change from baseline to the end of the trial in surrogate markers of phosphate balance (PTH, s-urea, s-creatinine, ionized Ca, phosphate).
Time frame: Week 12
Change from baseline to end of the study in markers of lipid homeostasis (total cholesterol, LDL, HDL, ApoA, ApoB, TG, free fatty acids)
Time frame: Week 12
Change from baseline to the end of the study in circulating inflammatory cytokines (hsCRP, TNF, fibrinogen, PAI, fetuin)
Time frame: Week 12
Number of adverse events directly attributable to sevelamer or calciumcarbonate treatments.
Time frame: Weekly until end of study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2012.
- Background: PubMed 12629079Soonthornpun S, Setasuban W, Thamprasit A, Chayanunnukul W, Rattarasarn C, Geater A. Novel insulin sensitivity index derived from oral glucose tolerance test. J Clin Endocrinol Metab. 2003 Mar;88(3):1019-23. doi: 10.1210/jc.2002-021127.
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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.
Anders Alvestrand, MD PhD principal investigator
Karolinska Institutet
Jonas Axelsson, MD, PhD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevelamer and Calcium carbonate in people with Kidney Failure, Chronic and End-Stage Renal Disease, run by Karolinska Institutet at 2 sites in Sweden.
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 1 inclusion and 10 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: withdrawn, as of the sponsor's last update on 26 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in insulin sensitivity and/or glucose tolerance from baseline to the end of the study, as obtained by ISIOGTT. (time frame: Week 12). 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 NCT00837655, 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 26 Sep 2012.