Efficacy and safety of a Double Icodextrin Dose in ederly patients, starting treatment by Continuous Ambulatory Peritoneal Dialysis (CAPD)

Efficacy and safety of a Double Icodextrin Dose in elderly incident CAPD patients on incremental Peritoneal Dialysis therapy: the DIDo study - DIDo

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005274-30-FR

Enrollment

160

Registered

2012-08-23

Start date

2012-08-08

Completion date

Unknown

Last updated

2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with chronic renal failure who are starting a Continuous Ambulatory Peritoneal Dialysis (CAPD) as first line dialyse. MedDRA version: 15.0 Level: LLT Classification code 10007184 Term: CAPD System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Extraneal Pharmaceutical Form: Solution for intraperitoneal use INN or Proposed INN: ICODEXTRIN CAS Number: 337376-15-5 Concentration unit: % percent Concentration type: equal Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Run-in period - Incident CAPD patients who require incremental PD and in whom a 2L dialysate can be safely instilled, - Creatinine clearance =65 years) yes F.1.3.1 Number of subjects for this age range 160

Exclusion criteria

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 the signature of the informed consent form, - History of drug or alcohol abuse within 3 months prior to the signature of the informed consent form. Treatment period - Severe symptomatic arterial hypotension at the end of 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, psycho-social reasons).

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the superiority and safety of using 2, as compared to 1, icodextrin bags / day, in a cohort of elderly incident CAPD patients using incremental PD (3 bags / day), with the aim of prolonging the period of time for which incremental PD can be used.;Secondary Objective: The secondary objective is to demonstrate the efficacy of the double icodextrin dose on various clinical and biological determinants as well as on safety issues. ;Primary end point(s): 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 period, - Transfer of the patient to another dialysis method (haemodialysis [HD], automated peritoneal dialysis [APD], CAPD with > 3 bags / day) for any reason, - Death of the patient. ;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated at 9 months (visit 5)	—

Measure

Time frame

Main Objective: To demonstrate the superiority and safety of using 2, as compared to 1, icodextrin bags / day, in a cohort of elderly incident CAPD patients using incremental PD (3 bags / day), with the aim of prolonging the period of time for which incremental PD can be used.;Secondary Objective: The secondary objective is to demonstrate the efficacy of the double icodextrin dose on various clinical and biological determinants as well as on safety issues. ;Primary end point(s): 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 period, - Transfer of the patient to another dialysis method (haemodialysis [HD], automated peritoneal dialysis [APD], CAPD with > 3 bags / day) for any reason, - Death of the patient. ;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated at 9 months (visit 5)

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Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoints will demonstrate the efficacy of the double icodextrin dose on various clinical and biological determinants as well as on safety issues: - Metabolic control: glycosylated haemoglobin (HbA1c) and lipid concentration total, high-density lipoprotein [HDL], low-density lipoprotein [LDL], triglycerides, cholesterol), - Blood pressure control, evaluated by the number of anti-hypertensive agents and daily furosemide dose, and measured at the end of each study visit, - Nutritional aspect: serum albumin and prealbumin concentrations based on the changes in percentage at various time points compared to baseline (V2), - Inflammatory profile: C-reactive protein (CRP) concentrations, - Left ventricular mass calculated following ECG, - Quality of life according to the kidney disease quality of life (KDQoL) evaluation, - Residual renal function evaluated by calculated glomerular filtration rate (GFR, creatinine + urea clearances/2), - Peritoneal membrane permeability assessed by the peritoneal equilibration test (PET), - Number of hospitalisations and length (in days) of hospitalisation, - Adverse events (AEs), treatment-emergent AEs and serious adverse events (SAEs), - Serum sodium concentration and icodextrin metabolites concentration, - Relevant clinical problems related to serum sodium concentration and to icodextrin metabolites accumulation, - Incidence of skin rashes, - Incidence of sterile peritonitis.;Timepoint(s) of evaluation of this end point: All secondary variables will be summarised and compared between groups at each time point: - V2 (D0), V4 (M6), V6 (M12) and V7 (M18) for all variables except left ventricular mass which is not measured at V4 and V6, - V3 (M3) for all except quality of life, peritoneal membrane permeability (by PET) and left ventricular mass, - V5 (M9) for all except quality of life and peritoneal membrane permeability (by PET). In addition, change and percent change from baseline (V	—

Measure

Time frame

Secondary end point(s): The secondary endpoints will demonstrate the efficacy of the double icodextrin dose on various clinical and biological determinants as well as on safety issues: - Metabolic control: glycosylated haemoglobin (HbA1c) and lipid concentration total, high-density lipoprotein [HDL], low-density lipoprotein [LDL], triglycerides, cholesterol), - Blood pressure control, evaluated by the number of anti-hypertensive agents and daily furosemide dose, and measured at the end of each study visit, - Nutritional aspect: serum albumin and prealbumin concentrations based on the changes in percentage at various time points compared to baseline (V2), - Inflammatory profile: C-reactive protein (CRP) concentrations, - Left ventricular mass calculated following ECG, - Quality of life according to the kidney disease quality of life (KDQoL) evaluation, - Residual renal function evaluated by calculated glomerular filtration rate (GFR, creatinine + urea clearances/2), - Peritoneal membrane permeability assessed by the peritoneal equilibration test (PET), - Number of hospitalisations and length (in days) of hospitalisation, - Adverse events (AEs), treatment-emergent AEs and serious adverse events (SAEs), - Serum sodium concentration and icodextrin metabolites concentration, - Relevant clinical problems related to serum sodium concentration and to icodextrin metabolites accumulation, - Incidence of skin rashes, - Incidence of sterile peritonitis.;Timepoint(s) of evaluation of this end point: All secondary variables will be summarised and compared between groups at each time point: - V2 (D0), V4 (M6), V6 (M12) and V7 (M18) for all variables except left ventricular mass which is not measured at V4 and V6, - V3 (M3) for all except quality of life, peritoneal membrane permeability (by PET) and left ventricular mass, - V5 (M9) for all except quality of life and peritoneal membrane permeability (by PET). In addition, change and percent change from baseline (V

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Countries

Belgium, France, United Kingdom

Contacts

Public ContactClinical Project Manager

Keyrus Biopharma

mariette.codou@keyrus.com33141342828

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026