| Trial ID: | L1368 |
| Source ID: | NCT00837655
|
| Associated Drug: |
Sevelamer
|
| Title: |
Effect of Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure (CKD)
|
| Acronym: |
SIR
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Failure, Chronic|End-Stage Renal Disease|Insulin Resistance|Hyperphosphatemia
|
| Interventions: |
DRUG: Sevelamer|DRUG: Calcium carbonate
|
| Outcome Measures: |
Primary: Change in insulin sensitivity and/or glucose tolerance from baseline to the end of the study, as obtained by ISIOGTT., Week 12 | Secondary: Change from baseline to the end of the trial in surrogate markers of phosphate balance (PTH, s-urea, s-creatinine, ionized Ca, phosphate)., 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), Week 12|Change from baseline to the end of the study in circulating inflammatory cytokines (hsCRP, TNF, fibrinogen, PAI, fetuin), Week 12|Number of adverse events directly attributable to sevelamer or calciumcarbonate treatments., Weekly until end of study
|
| Sponsor/Collaborators: |
Sponsor: Karolinska Institutet | Collaborators: Göteborg University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-01
|
| Completion Date: |
2011-06
|
| Results First Posted: |
|
| Last Update Posted: |
2012-09-26
|
| Locations: |
Sahlgrenska University Hospital, Gothenburg, 413 45, Sweden|Karolinska University Hospital, Stockholm, 14186, Sweden
|
| URL: |
https://clinicaltrials.gov/show/NCT00837655
|
