Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental PD.
NCT ID: NCT01944852
Last Updated: 2020-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
117 participants
INTERVENTIONAL
2013-03-31
2020-02-28
Brief Summary
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* 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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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2 icodextrin bags/day
2 icodextrin bags + 1 glucose per day
Icodextrin
1 icodextrin bag/day
1 icodextrin bag + 2 glucose bags per day
Icodextrin
Interventions
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Icodextrin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
60 Years
ALL
No
Sponsors
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Pr Eric Goffin
OTHER
Responsible Party
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Pr Eric Goffin
Professor
Principal Investigators
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Eric Goffin
Role: PRINCIPAL_INVESTIGATOR
UCL
Locations
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Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Countries
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References
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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.
Other Identifiers
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UCL_2011_DIDo
Identifier Type: -
Identifier Source: org_study_id