NCT01944852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 18, 2013

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

7 years

First QC Date

September 2, 2013

Last Update Submit

November 8, 2020

Conditions

Renal Insufficiency

Keywords

icodextrindouble doseelderly incident CAPD patientsDIDo study

Outcome Measures

Primary Outcomes (1)

  • 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.

    During the treatment phase of 18 months

Secondary Outcomes (14)

  • effect on clinical and biological determinants

    During 18 months, evaluated on month 3, 6, 9, 12 and 18.

  • effect on clinical and biological determinants

    During 18 months, evaluated on month 3, 6, 9, 12 and 18.

  • effect on clinical and biological determinants

    During 18 months, evaluated on month 3, 6, 9, 12 and 18.

  • effect on clinical and biological determinants

    During 18 months, evaluated on month 3, 6, 9, 12 and 18.

  • effect on clinical and biological determinants

    Month 9 and month 18.

  • +9 more secondary outcomes

Study Arms (2)

2 icodextrin bags/day

EXPERIMENTAL

2 icodextrin bags + 1 glucose per day

Drug: Icodextrin

1 icodextrin bag/day

ACTIVE COMPARATOR

1 icodextrin bag + 2 glucose bags per day

Drug: Icodextrin

Interventions

IcodextrinDRUG
Also known as: Extraneal
1 icodextrin bag/day2 icodextrin bags/day

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Related Publications (1)

  • Morelle J, Lambie M, Oberg CM, Davies S. The Peritoneal Membrane and Its Role in Peritoneal Dialysis. Clin J Am Soc Nephrol. 2024 Feb 1;19(2):244-253. doi: 10.2215/CJN.0000000000000282. Epub 2023 Aug 24.

    PMID: 37616463DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Icodextrin

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydrates

Study Officials

  • Eric Goffin

    UCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 2, 2013

First Posted

September 18, 2013

Study Start

March 1, 2013

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

November 10, 2020

Record last verified: 2020-11

Locations

BE(1)