Disorders Associated With Peritoneal DialysisPhase 4STARCHNCT01021878
Study to Evaluate the Effects Icodextrin Versus Dianeal on Insulin Resistance in Nondiabetic Automated Peritoneal Dialysis Patients
A Phase 4 study testing icodextrin and Dianeal in people with Disorders Associated With Peritoneal Dialysis, run by Pontifícia Universidade Católica do Paraná at 8 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Disorders Associated With Peritoneal Dialysis
- What is being tested?
- icodextrin and Dianeal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 8 sitesBrazil
- Study dates
- Oct 2009to Feb 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Brazil8 sites
Clinese
Aracaju, Sergipe, 49075210
Universidade Estadual Paulista
Botucatu, São Paulo, 18618970
Nefroclinica de Caxias do Sul
Caxias do Sul, Rio Grande do Sul, 95010-003
Clinica de Doencas Renais
Curitiba, Paraná, 80220901
Instituto do Rim de Curitiba
Curitiba, Paraná, 80250-070
Hospital São João de Deus
Divinópolis, Minas Gerais
Universidade Federal de Sao Paulo
São Paulo, São Paulo, 04023 062
Universidade Federal de Uberlândia
Uberlândia, Minas Gerais, 38400 089
About this study
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
- LOCATION OF STUDY: Multicentric study in Brazil.
- 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.
- 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
Read more
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.
Read the detailed description
- SUMMARY OF THE STUDY
1.1 PROTOCOLE TITLE : A RANDOMIZED, OPEN-LABEL CLINICAL TRIAL TO EVALUATE THE EFFECTS OF ICODEXTRIN Vs 2,5% DIANEAL USED FOR THE LONG-DWELL ON HOMA INDEX IN PREVALENT, NON-DIABETIC, PATIENTS IN AUTOMATED PERITONEAL DIALYSIS (APD)
1.2 MAIN RESEARCHERS: Roberto Pecoits Filho, Thyago P. Moraes
1.3 LOCATION OF STUDY: Multicentric study in Brazil.
1.4 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.
1.5 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.
1.6 SECONDARY OUTCOMES:
1.6.1 Other efficacy outcomes were total UF, long-dwell UF, and preprandial glycemia (taken first in the morning before breakfast), serum insulin levels and glycated haemoglobin.
1.6.2 The incidence of adverse events will be measured as a safety outcome.
1.7 STAGE OF THE STUDY : Phase IV postmarket study
1.8 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.
1.9 SAMPLE SIZE: Randomization Upon completion of the study TOTAL: 100 60 ExtranealTM 50 30 Dianeal® 50 30
1.12 PHARMACEUTICAL FORM, ROUTE OF DE ADMINISTRATION AND DOSAGE
ExtranealTM (7.5% Icodextrin) solution for Peritoneal Dialysis:
It is labelled as "solution for dialysis" to be administered within the study for a period of one (1) year.
Available in 2 liter bags of peritoneal dialysis solution (Twin Bag) for CAPD, this product will be used during the long-dwell.
Dianeal® PD4 (2.5% Dextrose) solution for Peritoneal Dialysis:
It is labelled as 2.27% glucose-based "solution for dialysis", to be administered within the study for a period of one (1) year.
Available in 2 and 2.5 liter bags of peritoneal dialysis solution (Twin Bag) for CAPD, this product will be used during the long-dwell.
Duration: 1 year.
- Being tested
- icodextrin, Dianeal
- Keywords
- Peritoneal dialysis, Renal replacement therapy, Dialysis solutions, Icodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
icodextrinOther
Also called Extraneal
glucose sparing dialysis solution
DianealOther
glucose based dialysis solution
| Study group | Role | What they receive |
|---|---|---|
| icodextrin | Experimental | glucose sparing alternative dialysis solution Receives: Other: icodextrin |
| dextrose | Active comparator | dianeal, Control group, standard treatment Receives: Other: Dianeal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor
Adjusted HOMA index score at 3 months using baseline values as a covariate and groups as the fixed factor. HOMA index was calculated as follows:
(fasting glucose(mg/dl) x fasting serum insulin (μU/mL))/405
Measured: 3 months
Secondary outcomes (4)
Oral Fasting Serum Glucose
Serum glucose measured in oral fasting but not peritoneal fasting.
For this outcome we compared groups using analysis of covariance (ANCOVA) using the baseline values as covariate, groups as the fixed factor and the value obtained at 90 days as the dependent variable. Significance level for alpha was setting at < 0.05.
Measured: 3 months
Serum Insulin
Serum insulin was log-transformed to meet all criteria for ANCOVA. The baseline value was treated as covariate, groups as the fixed factor and the serum insulin at 3 months as the dependent variable. Serum insulin was measured in oral fasting by chemioluminescense.
Measured: 3 months
Glycated Hemoglobin
Adjusted glycated hemoglobin was obtained and compared between groups using analysis of covariance (ANCOVA). The baseline values of HbA1c was used as covariate, the groups as the fixed factor and the value obtained at 90 days as the dependent variable.
Glycated hemoglobin was measured by high-performance liquid chromatography.
Measured: 3 months
Total Ultrafiltration
Total ultrafiltration obtained in 24 hours was obtained and compared between groups using analysis of covariance (ANCOVA). The baseline values of total ultrafiltration was used as covariate, the groups as the fixed factor and the value obtained at 90 days as the dependent variable.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Disorders Associated With Peritoneal DialysisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontifícia Universidade Católica do Paraná
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Roberto Pecoits-Filho, Pontifícia Universidade Católica do Paraná
- Investigators
- Roberto Pecoits-Filho, MD, PhD, Principal investigator, Pontificia Universidade Catolica do Parana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021878
- Sponsor's protocol ID
- PUCPR 01
- Acronym
- STARCH
- Status last verified
- Sep 2014
- First submitted
- 27 Nov 2009
- Last updated
- 1 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01021878
- Acronym / sponsor ID
- STARCH / PUCPR 01
- Keywords
- Peritoneal dialysis, Renal replacement therapy, Dialysis solutions, Icodextrin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pontifícia Universidade Católica do ParanáUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Oct 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 30 Nov 2009 (estimated)
- Results
- Posted 1 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- LOCATION OF STUDY: Multicentric study in Brazil.
- 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.
- 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.
Detailed description
- SUMMARY OF THE STUDY
1.1 PROTOCOLE TITLE : A RANDOMIZED, OPEN-LABEL CLINICAL TRIAL TO EVALUATE THE EFFECTS OF ICODEXTRIN Vs 2,5% DIANEAL USED FOR THE LONG-DWELL ON HOMA INDEX IN PREVALENT, NON-DIABETIC, PATIENTS IN AUTOMATED PERITONEAL DIALYSIS (APD)
1.2 MAIN RESEARCHERS: Roberto Pecoits Filho, Thyago P. Moraes
1.3 LOCATION OF STUDY: Multicentric study in Brazil.
1.4 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.
1.5 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.
1.6 SECONDARY OUTCOMES:
1.6.1 Other efficacy outcomes were total UF, long-dwell UF, and preprandial glycemia (taken first in the morning before breakfast), serum insulin levels and glycated haemoglobin.
1.6.2 The incidence of adverse events will be measured as a safety outcome.
1.7 STAGE OF THE STUDY : Phase IV postmarket study
1.8 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.
1.9 SAMPLE SIZE: Randomization Upon completion of the study TOTAL: 100 60 ExtranealTM 50 30 Dianeal® 50 30
1.12 PHARMACEUTICAL FORM, ROUTE OF DE ADMINISTRATION AND DOSAGE
ExtranealTM (7.5% Icodextrin) solution for Peritoneal Dialysis:
It is labelled as "solution for dialysis" to be administered within the study for a period of one (1) year.
Available in 2 liter bags of peritoneal dialysis solution (Twin Bag) for CAPD, this product will be used during the long-dwell.
Dianeal® PD4 (2.5% Dextrose) solution for Peritoneal Dialysis:
It is labelled as 2.27% glucose-based "solution for dialysis", to be administered within the study for a period of one (1) year.
Available in 2 and 2.5 liter bags of peritoneal dialysis solution (Twin Bag) for CAPD, this product will be used during the long-dwell.
Duration: 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| icodextrin | Experimental | Other: icodextringlucose sparing alternative dialysis solution |
| dextrose | Active comparator | Other: Dianealdianeal, Control group, standard treatment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| icodextrinAlso: Extranealglucose sparing dialysis solution | Other | icodextrin |
| Dianealglucose based dialysis solution | Other | dextrose |
Primary outcome
Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor
Time frame: 3 months
Adjusted HOMA index score at 3 months using baseline values as a covariate and groups as the fixed factor. HOMA index was calculated as follows: (fasting glucose(mg/dl) x fasting serum insulin (μU/mL))/405
4 secondary outcomes
Oral Fasting Serum Glucose
Time frame: 3 months
Serum Insulin
Time frame: 3 months
Glycated Hemoglobin
Time frame: 3 months
Total Ultrafiltration
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Roberto Pecoits-Filho, MD, PhD principal investigator
Pontificia Universidade Catolica do Parana
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing icodextrin and Dianeal in people with Disorders Associated With Peritoneal Dialysis, run by Pontifícia Universidade Católica do Paraná at 8 sites in Brazil.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2014.