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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01944852
Recruitment Status : Active, not recruiting
First Posted : September 18, 2013
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Pr Eric Goffin, Université Catholique de Louvain

Tracking Information
First Submitted Date  ICMJE September 2, 2013
First Posted Date  ICMJE September 18, 2013
Last Update Posted Date October 14, 2019
Actual Study Start Date  ICMJE March 2013
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2013)
Proportion of patients stopping 3 bags / day [ Time Frame: Until 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2014)
  • 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)
  • 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
  • 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)
  • effect on clinical and biological determinants [ Time Frame: During 18 months, evaluated on month 3, 6, 9, 12 and 18. ]
    • Inflammatory profile: CRP concentrations
  • effect on clinical and biological determinants [ Time Frame: Month 9 and month 18. ]
    • Left ventricular mass calculated following echocardiography
  • effect on clinical and biological determinants [ Time Frame: Month 6, 12 and 18. ]
    • Quality of life according to KDQoL
  • 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
  • effect on clinical and biological determinants [ Time Frame: On month 6, 12 and 18. ]
    • Peritoneal membrane permeability assessed by the PET
  • effect on clinical and biological determinants [ Time Frame: During the treatment phase of 18 months. ]
    • Number of hospitalisations and length (in days) of hospitalisation
  • Safety endpoints [ Time Frame: Durign the treatment phase of 18 months. ]
    • Adverse events (AEs), treatment-emergent AEs and serious adverse events (SAEs)
  • 6.1.3 Safety endpoints [ Time Frame: On month 3, 6, 12 and 18. ]
    • Serum sodium concentration and icodextrin metabolites concentration
  • safety endpoints [ Time Frame: During the treatment phase of 18 months. ]
    • Relevant clinical problems related to serum sodium concentration and to icodextrin metabolites accumulation
  • Safety endpoints [ Time Frame: During the treatment phase of 18 months. ]
    • Incidence of skin rashes
  • Safety endpoints [ Time Frame: During the treatment phase of 18 months. ]
    • Incidence of sterile peritonitis
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2013)
  • effect on clinical and biological determinants [ Time Frame: Until 18 months ]
    • Metabolic control: HbA1c and lipid concentration (total, high-density lipoprotein [HDL], low-density lipoprotein [LDL], triglycerides, cholesterol)
  • effect on clinical and biological determinants [ Time Frame: Until 18 months ]
    • 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 [ Time Frame: Until 18 months ]
    • 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 [ Time Frame: Until 18 months ]
    • Inflammatory profile: CRP concentrations
  • effect on clinical and biological determinants [ Time Frame: Until 18 months ]
    • Left ventricular mass calculated following echocardiography
  • effect on clinical and biological determinants [ Time Frame: Until 18 months ]
    • Quality of life according to KDQoL
  • effect on clinical and biological determinants [ Time Frame: Until 18 months ]
    • Residual renal function evaluated by calculated GFR
  • effect on clinical and biological determinants [ Time Frame: Until 18 months ]
    • Peritoneal membrane permeability assessed by the PET
  • effect on clinical and biological determinants [ Time Frame: Until 18 months ]
    • Number of hospitalisations and length (in days) of hospitalisation
  • Safety endpoints [ Time Frame: Until 18 months ]
    • Adverse events (AEs), treatment-emergent AEs and serious adverse events (SAEs)
  • 6.1.3 Safety endpoints [ Time Frame: Until 18 months ]
    • Serum sodium concentration and icodextrin metabolites concentration
  • safety endpoints [ Time Frame: Until 18 months ]
    • Relevant clinical problems related to serum sodium concentration and to icodextrin metabolites accumulation
  • Safety endpoints [ Time Frame: Until 18 months ]
    • Incidence of skin rashes
  • Safety endpoints [ Time Frame: Until 18 months ]
    • Incidence of sterile peritonitis
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental PD.
Official Title  ICMJE Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental Peritoneal Dialysis Therapy: the DIDo Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Insufficiency
Intervention  ICMJE Drug: Icodextrin
Other Name: Extraneal
Study Arms  ICMJE
  • Experimental: 2 icodextrin bags/day
    2 icodextrin bags + 1 glucose per day
    Intervention: Drug: Icodextrin
  • Active Comparator: 1 icodextrin bag/day
    1 icodextrin bag + 2 glucose bags per day
    Intervention: Drug: Icodextrin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 10, 2019)
117
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2013)
160
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01944852
Other Study ID Numbers  ICMJE UCL_2011_DIDo
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pr Eric Goffin, Université Catholique de Louvain
Study Sponsor  ICMJE Pr Eric Goffin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Goffin UCL
PRS Account Université Catholique de Louvain
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP