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

Renal Insufficiency Clinical Trial

— DIDo  

Official title:

Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental Peritoneal Dialysis Therapy: the DIDo Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944852
• Other study ID #: UCL_2011_DIDo
• Status: Completed
• Phase: Phase 4
• Start date: March 2013
• Est. completion date: February 28, 2020

Study information

• Verified date: November 2020
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Drug:
• Icodextrin

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pr Eric Goffin

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	effect on clinical and biological determinants	• Metabolic control: HbA1c and lipid concentration (total, high-density lipoprotein [HDL], low-density lipoprotein [LDL], triglycerides, cholesterol)	During 18 months, evaluated on month 3, 6, 9, 12 and 18.
Secondary	effect on clinical and biological determinants	• Blood pressure control, evaluated by the number of anti-hypertensive agents and daily furosemide dose, and measured at the end of each study visit	During 18 months, evaluated on month 3, 6, 9, 12 and 18.
Secondary	effect on clinical and biological determinants	• Nutritional aspect: serum albumin and prealbumin concentrations based on the changes in percentage at various time points compared to baseline (V2)	During 18 months, evaluated on month 3, 6, 9, 12 and 18.
Secondary	effect on clinical and biological determinants	• Inflammatory profile: CRP concentrations	During 18 months, evaluated on month 3, 6, 9, 12 and 18.
Secondary	effect on clinical and biological determinants	• Left ventricular mass calculated following echocardiography	Month 9 and month 18.
Secondary	effect on clinical and biological determinants	• Quality of life according to KDQoL	Month 6, 12 and 18.
Secondary	effect on clinical and biological determinants	• Residual renal function evaluated by calculated GFR	During 18 months, evaluated on month 3, 6, 9, 12 and 18.
Secondary	effect on clinical and biological determinants	• Peritoneal membrane permeability assessed by the PET	On month 6, 12 and 18.
Secondary	effect on clinical and biological determinants	• Number of hospitalisations and length (in days) of hospitalisation	During the treatment phase of 18 months.
Secondary	Safety endpoints	• Adverse events (AEs), treatment-emergent AEs and serious adverse events (SAEs)	Durign the treatment phase of 18 months.
Secondary	6.1.3 Safety endpoints	• Serum sodium concentration and icodextrin metabolites concentration	On month 3, 6, 12 and 18.
Secondary	safety endpoints	• Relevant clinical problems related to serum sodium concentration and to icodextrin metabolites accumulation	During the treatment phase of 18 months.
Secondary	Safety endpoints	• Incidence of skin rashes	During the treatment phase of 18 months.
Secondary	Safety endpoints	• Incidence of sterile peritonitis	During the treatment phase of 18 months.