Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental PD. (DIDo)

November 8, 2020 updated by: Pr Eric Goffin

Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental Peritoneal Dialysis Therapy: the DIDo Study

The DIDo study is an open-label, randomised, multicentre study with 2 parallel groups in incident CAPD patients aged of 65 at minimum :

  • One group in which patients will receive 2 bags of icodextrin/day and 1 bag of glucose
  • One group in which patients will receive 1 bag of icodextrin/day and 2 bags of glucose.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The DiDo study evaluates efficacy and safety of a Double Icodextrin Dose in elderly incident CAPD patients on incremental Peritoneal Dialysis therapy.

The objective is to demonstrate the superiority and safety of using 2, as compared to 1, icodextrin bags / day, in a cohort of elderly incident continuous ambulatory peritoneal dialysis (CAPD) patients using incremental peritoneal dialysis (PD) (3 bags / day), with the aim of prolonging the period of time for which incremental PD can be used.

This is a phase IV open-label, randomised, multicentre study with 2 parallel groups, which will take place in up to 30 hospital out-patient clinics un Europe.

It is planned to include 160 patients on the run-in period in order to obtain 100 randomised patients and 90 patients evaluable at the primary endpoint (45 in each group). The duration of patient recruitment is estimated at 1 year but this may be extended until all 160 patients are recruited.

There are 2 periods: a run-in period of 2 months and a treatment period of 18 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
117

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Run-in period

  • Incident CAPD patients who require incremental PD and in whom a 1.5L dialysate can be safely instilled,
  • Creatinine clearance < 20 ml / min (calculated with the modification of the Diet in renal Disease [MDRD] formula),
  • Age ≥ 60 years,
  • Patients willing and able to give written informed consent and comply with the requirements of the study protocol.

Treatment period

  • Patients having successfully completed the run-in period (achieving euvolemia)

Exclusion Criteria:

Run-in period

  • Contraindication for CAPD according to local practice,
  • Life expectancy < 6 months,
  • Known allergy to icodextrin (cloudy dialysate or skin rash),
  • Need for amino-acid prescription,
  • Treatment with any investigational product within 30 days prior to signature of the informed consent form (ICF)
  • History of drug or alcohol abuse within 3 months prior to the signature of the ICF.

Treatment period

  • Severe symptomatic arterial hypotension at the end the run-in period in the Investigator's opinion,
  • Excessive ultrafiltration (UF) during the run-in period,
  • Allergy to icodextrin discovered during the run-in period,
  • Impossibility to achieve adequate PD regimen within the run-in period (catheter dysfunction, peritoneal leaks, inadequate compliance, psychosocial reasons)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 2 icodextrin bags/day
2 icodextrin bags + 1 glucose per day
Drug: Icodextrin
Other Names:
  • Extraneal
Active Comparator: 1 icodextrin bag/day
1 icodextrin bag + 2 glucose bags per day
Drug: Icodextrin
Other Names:
  • Extraneal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients stopping 3 bags / day
Time Frame: During the treatment phase of 18 months

The primary endpoint will be the proportion of patients stopping 3 bags / day for the following reasons:

  • Use of > 15 % hypertonic glucose dialysate 3.86 % or > 30 % hypertonic glucose dialysate 2.27 % over a 4-week period19-20,
  • Transfer of the patient to another dialysis method (HD, APD, CAPD with > 3 bags / day) for any reason,
  • Death of the patient.
During the treatment phase of 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
effect on clinical and biological determinants
Time Frame: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
• Metabolic control: HbA1c and lipid concentration (total, high-density lipoprotein [HDL], low-density lipoprotein [LDL], triglycerides, cholesterol)
During 18 months, evaluated on month 3, 6, 9, 12 and 18.
effect on clinical and biological determinants
Time Frame: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
• Blood pressure control, evaluated by the number of anti-hypertensive agents and daily furosemide dose, and measured at the end of each study visit
During 18 months, evaluated on month 3, 6, 9, 12 and 18.
effect on clinical and biological determinants
Time Frame: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
• Nutritional aspect: serum albumin and prealbumin concentrations based on the changes in percentage at various time points compared to baseline (V2)
During 18 months, evaluated on month 3, 6, 9, 12 and 18.
effect on clinical and biological determinants
Time Frame: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
• Inflammatory profile: CRP concentrations
During 18 months, evaluated on month 3, 6, 9, 12 and 18.
effect on clinical and biological determinants
Time Frame: Month 9 and month 18.
• Left ventricular mass calculated following echocardiography
Month 9 and month 18.
effect on clinical and biological determinants
Time Frame: Month 6, 12 and 18.
• Quality of life according to KDQoL
Month 6, 12 and 18.
effect on clinical and biological determinants
Time Frame: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
• Residual renal function evaluated by calculated GFR
During 18 months, evaluated on month 3, 6, 9, 12 and 18.
effect on clinical and biological determinants
Time Frame: On month 6, 12 and 18.
• Peritoneal membrane permeability assessed by the PET
On month 6, 12 and 18.
effect on clinical and biological determinants
Time Frame: During the treatment phase of 18 months.
• Number of hospitalisations and length (in days) of hospitalisation
During the treatment phase of 18 months.
Safety endpoints
Time Frame: Durign the treatment phase of 18 months.
• Adverse events (AEs), treatment-emergent AEs and serious adverse events (SAEs)
Durign the treatment phase of 18 months.
6.1.3 Safety endpoints
Time Frame: On month 3, 6, 12 and 18.
• Serum sodium concentration and icodextrin metabolites concentration
On month 3, 6, 12 and 18.
safety endpoints
Time Frame: During the treatment phase of 18 months.
• Relevant clinical problems related to serum sodium concentration and to icodextrin metabolites accumulation
During the treatment phase of 18 months.
Safety endpoints
Time Frame: During the treatment phase of 18 months.
• Incidence of skin rashes
During the treatment phase of 18 months.
Safety endpoints
Time Frame: During the treatment phase of 18 months.
• Incidence of sterile peritonitis
During the treatment phase of 18 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pr Eric Goffin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric Goffin, UCL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UCL_2011_DIDo

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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