Phase 4
Completed N=60
Study to Evaluate the Effects Icodextrin Versus Dianeal on Insulin Resistance in Nondiabetic Automated Peritoneal Dialysis Patients
Disorders Associated With Peritoneal Dialysis
Source: ClinicalTrials.gov NCT01021878 ↗
Enrolled (actual)
60
Serious AEs
15.0%
Results posted
Oct 2014
Primary outcomePrimary: Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor — 1.49; 1.89 IR score
Summary
1. LOCATION OF STUDY: Multicentric study in Brazil.
2. PURPOSE OF THE STUDY: To measure changes in HOMA index when non-diabetic patients in APD were exposed to 7,5% Icodextrin for the long-dwell; and to compare such changes with those produced by 2,5% glucose for the long-dwell.
3. PRIMARY OUTCOME: The primary efficacy outcome was to measure HOMA index to set the differences with regard to baseline values of this variable for the two groups as well as in each group, which showed control of the glucose metabolism.
STAGE OF THE STUDY : Phase IV postmarket study
DESIGN: Randomized, open-label, multicenter study. Patients were randomized to receive either to Extraneal (7,5% Icodextrin) or 2.5% Dianeal during the long-dwell.
SAMPLE SIZE: Randomization Upon completion of the study TOTAL: 120 60 ExtranealTM 60 30 Dianeal® 60 30
Duration: 1 year.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor |
1.49; 1.89 | — |
| SECONDARY Oral Fasting Serum Glucose |
92.8; 94.5 | — |
| SECONDARY Serum Insulin |
0.79; 0.90 | — |
| SECONDARY Glycated Hemoglobin |
4.97; 4.86 | — |
| SECONDARY Total Ultrafiltration |
958; 656 | — |
Eligibility Criteria
Inclusion Criteria
- 1.10.1 Older than 18 years old.
- High PET value, average-high or average-low.
- Cause of renal chronic disease other than diabetes mellitus.
- Patient in APD
- Prevalent patient in APD (defined as at least 90 total days of dialysis therapy)
Exclusion Criteria
- Not willing to participate.
- A Charlson comorbidity index >7, or a life expectancy < 12 months as assessed by the treating physician.
- Positive VIH.
- Episodes of peritonitis during the month preceding the randomization.
- Significant cardiovascular, metabolic or infectious complications during the month preceding the randomization.
- Patients with active cancer.
- Patients with known allergies to corn starch polymers.
- Patients who are unable to provide an informed consent because of significant psychiatric disorder or mental illness
- Patients not meeting adequacy goals several months after the change in the dosage regime.
Data sourced from ClinicalTrials.gov (NCT01021878). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.