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Effect of Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure (CKD) (SIR)

Primary Purpose

Kidney Failure, Chronic, End-Stage Renal Disease, Insulin Resistance

Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Sevelamer
Calcium carbonate
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring Chronic kidney disease, End-stage renal disease, phosphate binder, insulin resistance, glucose intolerance, sevelamer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female patients 18-80 years of age with chronic renal failure treated with maintenance HD for >3 months.

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Sahlgrenska University Hospital
  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Sevelamer intervention

Calcium carbonate

Outcomes

Primary Outcome Measures

Change in insulin sensitivity and/or glucose tolerance from baseline to the end of the study, as obtained by ISIOGTT.

Secondary Outcome Measures

Change from baseline to the end of the trial in surrogate markers of phosphate balance (PTH, s-urea, s-creatinine, ionized Ca, phosphate).
Change from baseline to end of the study in markers of lipid homeostasis (total cholesterol, LDL, HDL, ApoA, ApoB, TG, free fatty acids)
Change from baseline to the end of the study in circulating inflammatory cytokines (hsCRP, TNF, fibrinogen, PAI, fetuin)
Number of adverse events directly attributable to sevelamer or calciumcarbonate treatments.

Full Information

First Posted
January 29, 2009
Last Updated
September 25, 2012
Sponsor
Karolinska Institutet
Collaborators
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT00837655
Brief Title
Effect of Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure (CKD)
Acronym
SIR
Official Title
Study of the Effect of Treatment With Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Withdrawn
Why Stopped
PI retired
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Karolinska Institutet
Collaborators
Göteborg University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic, End-Stage Renal Disease, Insulin Resistance, Hyperphosphatemia
Keywords
Chronic kidney disease, End-stage renal disease, phosphate binder, insulin resistance, glucose intolerance, sevelamer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Sevelamer intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
Calcium carbonate
Intervention Type
Drug
Intervention Name(s)
Sevelamer
Other Intervention Name(s)
Renagel
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Calcium carbonate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in insulin sensitivity and/or glucose tolerance from baseline to the end of the study, as obtained by ISIOGTT.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Change from baseline to the end of the study in circulating inflammatory cytokines (hsCRP, TNF, fibrinogen, PAI, fetuin)
Time Frame
Week 12
Title
Number of adverse events directly attributable to sevelamer or calciumcarbonate treatments.
Time Frame
Weekly until end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients 18-80 years of age with chronic renal failure treated with maintenance HD for >3 months. Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Alvestrand, MD PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonas Axelsson, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
12629079
Citation
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.
Results Reference
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Effect of Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure (CKD)

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