Clinical Trials Logo
  1. Home
  2. Renal Insufficiency
  3. NCT01944852

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

Renal Insufficiency Clinical Trial

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 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01944852
Study type Interventional
Source Université Catholique de Louvain
Contact
Status Completed
Phase Phase 4
Start date March 2013
Completion date February 28, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT05990660 - Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery N/A
Recruiting NCT04096547 - Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
Completed NCT04024332 - Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects Phase 1
Completed NCT02849964 - Factors Related to Geographical Variation in the Incidence of End-stage Renal Failure: An Analysis in 5 French Regions N/A
Active, not recruiting NCT03672110 - Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen Phase 3
Completed NCT01462136 - PK Study of ACHN-490 Injection in Renally Impaired Subjects Phase 1
Completed NCT01407874 - A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency Phase 2
Completed NCT01172431 - Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency Phase 4
Completed NCT00770081 - Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study) Phase 3
Completed NCT01545531 - Two-Point Measurement of Glomerular Filtration Rate by Iohexol Plasma Disappearance N/A
Completed NCT00765830 - Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency (28 Week Extension) Phase 3
Terminated NCT00338455 - Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC Phase 2
Completed NCT00159614 - Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment Phase 2
Completed NCT02894905 - A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of AL-335 Phase 1
Completed NCT02894385 - Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201) Phase 1
Active, not recruiting NCT04876963 - HOLT-ED: Holter-monitoring in End-stage Renal Disease
Not yet recruiting NCT03899298 - Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions Phase 1
Completed NCT03235375 - A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects Phase 1
Withdrawn NCT03329612 - Remote Ischemic Preconditioning in ACS Patients N/A
Recruiting NCT02578784 - DEB-after-Cutting Balloon-PTA in Dialysis Fistula Stenosis N/A