Clinical trial NCT01944852: Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental PD.
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Insufficiency
Keywords: icodextrin
double dose
elderly incident CAPD patients
DIDo study
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 117
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Proportion of patients stopping 3 bags / day
timeFrame: During the treatment phase of 18 months
Secondary outcomes:
measure: effect on clinical and biological determinants
timeFrame: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
measure: effect on clinical and biological determinants
timeFrame: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
measure: effect on clinical and biological determinants
timeFrame: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
measure: effect on clinical and biological determinants
timeFrame: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
measure: effect on clinical and biological determinants
timeFrame: Month 9 and month 18.
measure: effect on clinical and biological determinants
timeFrame: Month 6, 12 and 18.
measure: effect on clinical and biological determinants
timeFrame: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
measure: effect on clinical and biological determinants
timeFrame: On month 6, 12 and 18.
measure: effect on clinical and biological determinants
timeFrame: During the treatment phase of 18 months.
measure: Safety endpoints
timeFrame: Durign the treatment phase of 18 months.
measure: 6.1.3 Safety endpoints
timeFrame: On month 3, 6, 12 and 18.
measure: safety endpoints
timeFrame: During the treatment phase of 18 months.
measure: Safety endpoints
timeFrame: During the treatment phase of 18 months.
measure: Safety endpoints
timeFrame: During the treatment phase of 18 months.
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
affiliation: UCL
name: Eric Goffin
role: PRINCIPAL_INVESTIGATOR
References: