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

Primary Purpose

Renal Insufficiency

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Icodextrin
Sponsored by
Pr Eric Goffin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency focused on measuring icodextrin, double dose, elderly incident CAPD patients, DIDo study

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cliniques Universitaires Saint-Luc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

2 icodextrin bags/day

1 icodextrin bag/day

Arm Description

2 icodextrin bags + 1 glucose per day

1 icodextrin bag + 2 glucose bags per day

Outcomes

Primary Outcome Measures

Proportion of patients stopping 3 bags / day
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.

Secondary Outcome Measures

effect on clinical and biological determinants
• Metabolic control: HbA1c and lipid concentration (total, high-density lipoprotein [HDL], low-density lipoprotein [LDL], triglycerides, cholesterol)
effect on clinical and biological determinants
• Blood pressure control, evaluated by the number of anti-hypertensive agents and daily furosemide dose, and measured at the end of each study visit
effect on clinical and biological determinants
• Nutritional aspect: serum albumin and prealbumin concentrations based on the changes in percentage at various time points compared to baseline (V2)
effect on clinical and biological determinants
• Inflammatory profile: CRP concentrations
effect on clinical and biological determinants
• Left ventricular mass calculated following echocardiography
effect on clinical and biological determinants
• Quality of life according to KDQoL
effect on clinical and biological determinants
• Residual renal function evaluated by calculated GFR
effect on clinical and biological determinants
• Peritoneal membrane permeability assessed by the PET
effect on clinical and biological determinants
• Number of hospitalisations and length (in days) of hospitalisation
Safety endpoints
• Adverse events (AEs), treatment-emergent AEs and serious adverse events (SAEs)
6.1.3 Safety endpoints
• Serum sodium concentration and icodextrin metabolites concentration
safety endpoints
• Relevant clinical problems related to serum sodium concentration and to icodextrin metabolites accumulation
Safety endpoints
• Incidence of skin rashes
Safety endpoints
• Incidence of sterile peritonitis

Full Information

First Posted
September 2, 2013
Last Updated
November 8, 2020
Sponsor
Pr Eric Goffin
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1. Study Identification

Unique Protocol Identification Number
NCT01944852
Brief Title
Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental PD.
Acronym
DIDo
Official Title
Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental Peritoneal Dialysis Therapy: the DIDo Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pr Eric Goffin

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency
Keywords
icodextrin, double dose, elderly incident CAPD patients, DIDo study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2 icodextrin bags/day
Arm Type
Experimental
Arm Description
2 icodextrin bags + 1 glucose per day
Arm Title
1 icodextrin bag/day
Arm Type
Active Comparator
Arm Description
1 icodextrin bag + 2 glucose bags per day
Intervention Type
Drug
Intervention Name(s)
Icodextrin
Other Intervention Name(s)
Extraneal
Primary Outcome Measure Information:
Title
Proportion of patients stopping 3 bags / day
Description
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.
Time Frame
During the treatment phase of 18 months
Secondary Outcome Measure Information:
Title
effect on clinical and biological determinants
Description
• Metabolic control: HbA1c and lipid concentration (total, high-density lipoprotein [HDL], low-density lipoprotein [LDL], triglycerides, cholesterol)
Time Frame
During 18 months, evaluated on month 3, 6, 9, 12 and 18.
Title
effect on clinical and biological determinants
Description
• Blood pressure control, evaluated by the number of anti-hypertensive agents and daily furosemide dose, and measured at the end of each study visit
Time Frame
During 18 months, evaluated on month 3, 6, 9, 12 and 18.
Title
effect on clinical and biological determinants
Description
• Nutritional aspect: serum albumin and prealbumin concentrations based on the changes in percentage at various time points compared to baseline (V2)
Time Frame
During 18 months, evaluated on month 3, 6, 9, 12 and 18.
Title
effect on clinical and biological determinants
Description
• Inflammatory profile: CRP concentrations
Time Frame
During 18 months, evaluated on month 3, 6, 9, 12 and 18.
Title
effect on clinical and biological determinants
Description
• Left ventricular mass calculated following echocardiography
Time Frame
Month 9 and month 18.
Title
effect on clinical and biological determinants
Description
• Quality of life according to KDQoL
Time Frame
Month 6, 12 and 18.
Title
effect on clinical and biological determinants
Description
• Residual renal function evaluated by calculated GFR
Time Frame
During 18 months, evaluated on month 3, 6, 9, 12 and 18.
Title
effect on clinical and biological determinants
Description
• Peritoneal membrane permeability assessed by the PET
Time Frame
On month 6, 12 and 18.
Title
effect on clinical and biological determinants
Description
• Number of hospitalisations and length (in days) of hospitalisation
Time Frame
During the treatment phase of 18 months.
Title
Safety endpoints
Description
• Adverse events (AEs), treatment-emergent AEs and serious adverse events (SAEs)
Time Frame
Durign the treatment phase of 18 months.
Title
6.1.3 Safety endpoints
Description
• Serum sodium concentration and icodextrin metabolites concentration
Time Frame
On month 3, 6, 12 and 18.
Title
safety endpoints
Description
• Relevant clinical problems related to serum sodium concentration and to icodextrin metabolites accumulation
Time Frame
During the treatment phase of 18 months.
Title
Safety endpoints
Description
• Incidence of skin rashes
Time Frame
During the treatment phase of 18 months.
Title
Safety endpoints
Description
• Incidence of sterile peritonitis
Time Frame
During the treatment phase of 18 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Goffin
Organizational Affiliation
UCL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

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

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