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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

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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency Drug: Icodextrin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental Peritoneal Dialysis Therapy: the DIDo Study
Actual Study Start Date : March 2013
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Icodextrin

Arm Intervention/treatment
Experimental: 2 icodextrin bags/day
2 icodextrin bags + 1 glucose per day
Drug: Icodextrin
Other Name: Extraneal

Active Comparator: 1 icodextrin bag/day
1 icodextrin bag + 2 glucose bags per day
Drug: Icodextrin
Other Name: Extraneal




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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)

  4. effect on clinical and biological determinants [ Time Frame: During 18 months, evaluated on month 3, 6, 9, 12 and 18. ]
    • Inflammatory profile: CRP concentrations

  5. effect on clinical and biological determinants [ Time Frame: Month 9 and month 18. ]
    • Left ventricular mass calculated following echocardiography

  6. effect on clinical and biological determinants [ Time Frame: Month 6, 12 and 18. ]
    • Quality of life according to KDQoL

  7. 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

  8. effect on clinical and biological determinants [ Time Frame: On month 6, 12 and 18. ]
    • Peritoneal membrane permeability assessed by the PET

  9. effect on clinical and biological determinants [ Time Frame: During the treatment phase of 18 months. ]
    • Number of hospitalisations and length (in days) of hospitalisation

  10. Safety endpoints [ Time Frame: Durign the treatment phase of 18 months. ]
    • Adverse events (AEs), treatment-emergent AEs and serious adverse events (SAEs)

  11. 6.1.3 Safety endpoints [ Time Frame: On month 3, 6, 12 and 18. ]
    • Serum sodium concentration and icodextrin metabolites concentration

  12. safety endpoints [ Time Frame: During the treatment phase of 18 months. ]
    • Relevant clinical problems related to serum sodium concentration and to icodextrin metabolites accumulation

  13. Safety endpoints [ Time Frame: During the treatment phase of 18 months. ]
    • Incidence of skin rashes

  14. Safety endpoints [ Time Frame: During the treatment phase of 18 months. ]
    • Incidence of sterile peritonitis



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944852


Locations
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Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Pr Eric Goffin
Investigators
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Principal Investigator: Eric Goffin UCL

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Responsible Party: Pr Eric Goffin, Professor, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01944852    
Other Study ID Numbers: UCL_2011_DIDo
First Posted: September 18, 2013    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Keywords provided by Pr Eric Goffin, Université Catholique de Louvain:
icodextrin
double dose
elderly incident CAPD patients
DIDo study
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Icodextrin
Dialysis Solutions
Pharmaceutical Solutions