A Study to Evaluate the Effects of Icodextrin Versus 2.5% Dianeal on Insulin Resistance in Non Diabetic Apd Patients (STARCH)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Pontifícia Universidade Católica do Paraná.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Pontifícia Universidade Católica do Paraná
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Pontifícia Universidade Católica do Paraná
ClinicalTrials.gov Identifier:
NCT01021878
First received: November 27, 2009
Last updated: July 20, 2011
Last verified: November 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
- LOCATION OF STUDY: Multicentric study in Brazil.
- PURPOSE OF THE STUDY: To measure changes in glycated hemoglobin 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.
- PRIMARY OUTCOME: The primary efficacy outcome was to measure glycated hemoglobin 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Disorders Associated With Peritoneal Dialysis |
Other: icodextrin Other: Dianeal |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study to Evaluate the Effects of Icodextrin vs 2.5% Dianeal Used for the Long Dwell in Apd: a Randomized, Open-label Clinical Trial to Analyse the Insulin Resistance Using the Homa Index in Prevalent, Non-diabetic Patients |
Resource links provided by NLM:
Further study details as provided by Pontifícia Universidade Católica do Paraná:
Primary Outcome Measures:
- The primary efficacy outcome was to measure glycated hemoglobin 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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Serum lipids. Serum albumin. Total protein. Subjective Global Assessment (SGA). Number of hospitalization events. Time until hospitalization. Time of hospitalization. Number of antihypertensive drugs. Cost per type of therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Other efficacy outcomes were total UF, long-dwell UF, and preprandial glycemia (taken first in the morning before breakfast). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: icodextrin
glucose sparing alternative dialysis solution
|
Other: icodextrin
glucose sparing dialysis solution
Other Name: Extraneal
|
|
Active Comparator: dextrose
Control group, standard treatment
|
Other: Dianeal
glucose based dialysis solution
Other Name: Dianeal
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021878
Contacts
| Contact: Thyago Moraes, MD | +55 41 84028588 | thyagomoraes@hotmail.com |
Locations
| Brazil | |
| Universidade Federal de Uberlândia | Recruiting |
| Uberlândia, Minas Gerais, Brazil, 38400 089 | |
| Contact: Sebastião F Filho, MD +55 034 91299709 ferreirafilho1952@gmail.com | |
| Sub-Investigator: Sebastião F Filho, MD | |
| Instituto do Rim de Curitiba | Recruiting |
| Curitiba, Parana, Brazil, 80250-070 | |
| Contact: Gina Moreno, MD givanski@hotmail.com | |
| Sub-Investigator: Gina Moreno, MD | |
| Sub-Investigator: Helio V Cassi, MD | |
| Clinica de Doencas Renais | Recruiting |
| Curitiba, PR, Brazil, 80220901 | |
| Contact: Priscila Demetrio, Pharm +55 41 32713150 priscilahd@gmail.com | |
| Principal Investigator: Thyago Moraes, MD | |
| Nefroclinica de Caxias do Sul | Recruiting |
| Caxias do Sul, Rio Grande do Sul, Brazil, 95010-003 | |
| Contact: Dirceu R Silva, MD dirceucx@terra.com.br | |
| Sub-Investigator: Dirceu R Silva, MD | |
| Universidade Estadual Paulista | Recruiting |
| Botucatu, Sao Paulo, Brazil, 18618970 | |
| Contact: Jacqueline T Caramori, phD +55 14 38116143 jteixeir@fmb.unesp.br | |
| Sub-Investigator: Jacqueline CT Caramori, phD | |
| Instituto do Rim de Marília | Withdrawn |
| Marilia, Sao Paulo, Brazil, 17515-280 | |
| Clinese | Recruiting |
| Aracaju, Sergipe, Brazil, 49075210 | |
| Contact: Ubiratania Machado, MD tania@clinese.com.br | |
| Sub-Investigator: Kleyton A Bastos, MD | |
| Universidade Federal de Sao Paulo | Recruiting |
| Sao Paulo, Brazil, 04023 062 | |
| Contact: Suellen A Gonzales, Mrs +55 11 5904-8499 suellengonzales@hrim.com.br | |
| Sub-Investigator: Maria Eugênia F Canziani, phD | |
Sponsors and Collaborators
Pontifícia Universidade Católica do Paraná
Baxter Healthcare Corporation
Investigators
| Principal Investigator: | Roberto Pecoits-Filho, MD, PhD | Pontificia Universidade Catolica do Parana |
More Information
Additional Information:
No publications provided
| Responsible Party: | Roberto Pecoits-Filho, PUCPR |
| ClinicalTrials.gov Identifier: | NCT01021878 History of Changes |
| Other Study ID Numbers: | PUCPR 01 |
| Study First Received: | November 27, 2009 |
| Last Updated: | July 20, 2011 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Pontifícia Universidade Católica do Paraná:
|
Peritoneal dialysis Renal replacement therapy Dialysis solutions Icodextrin |
Additional relevant MeSH terms:
|
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013