Study of Safety and Efficacy on New Peritoneal Dialysis Solutions

NCT00858182 | Withdrawn Phase 2

• 1 other identifier: IP-001-07
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

A major challenge of peritoneal dialysis (PD) therapy is the development of glucose-sparing strategies able to provide an efficacious ultrafiltration (UF) profile. Study hypothesis is to evaluate the possibility to formulate PD solutions containing xylitol and L-carnitine as osmotic agents to partially replace glucose.

Conditions

End-Stage Renal Disease

Keywords

L-Carnitine; Xylitol; Peritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

• To assess ultrafiltration efficacy of PD solutions containing L-Carnitine and Xylitol

  4 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Drug: PD solution for nocturnal exchanges

Group B

EXPERIMENTAL

Drug: PD solution for diurnal exchanges

Interventions

PD solution for nocturnal exchanges DRUG

Instillation of a PD solution containing xylitol (1.5%), L-carnitine (0.1%) and glucose (0.5%) for the nocturnal exchange in CAPD treated patients. PD solutions are instilled for 4 weeks.

Group A

PD solution for diurnal exchanges DRUG

Instillation of a PD solution containing xylitol (0.6%), L-carnitine (0.1%) and glucose (0.5%) for the diurnal exchanges in CAPD treated patients. PD solutions are instilled for 4 weeks.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• Diagnosis of ESRD treated for at least three month with CAPD, as stated by the medical staff of the center;
• CAPD treatment with 2.27% of glucose solution for the nocturnal exchange;
• Stable clinical condition within four weeks before screening period, certified by medical/surgical history, physical examination and laboratory exploration;
• Hemoglobin level ≥9g/dL;
• Residual diuresis ≤800mL;
• Absence of acute peritonitis and/or peritoneal catheter infection (either exit site or subcutaneous tunnel) episodes within three months before selection;
• Stable peritoneal permeability, as confirmed by a PET between 0.50 and 0.81 during previous three months and at day 0 of the screening period;
• Total urea Kt/V \>1.5 per week at a control during previous three months and at day 0 of the screening period and/or minimal total creatinine clearance of 45 liter/week at a control during previous three months and at day 0 of the screening period; 1- To understand and sign an informed consent form.
• For patients who will be included in Group B, the following criteria must be fulfilled too:
• Be treated with Extraneal (nocturnal exchange bag solution) for at least 1 month
• Be treated with 2 or 3 diurnal exchange bag solutions (solution bags with 1.36% or 2.27% glucose) and one nocturnal exchange bag solution (Extraneal)

You may not qualify if:

• History of alcohol or drug abuse in the last six months before selection for the study;
• Androgen therapy in the last six months before selection;
• Active infections;
• History of congestive heart failure stage III and IV NYHA;
• History of major cardiovascular events like stroke, acute myocardial infarction, coronary or other arterial revascularization procedures in the last three months before selection;
• Clinically relevant cardiac arrhythmia;
• Clinically relevant abnormalities of functional hepatic tests;
• Therapy with L-carnitine or its derivatives in the last three months before selection;
• Pregnancy, lactating women or female subjects of childbearing potential who do not use an effective method of contraception;
• Participation in another clinical study within the past month;
• Known or supposed allergic reactions to L-carnitine or xylitol.

Sponsors & Collaborators

• Iperboreal Pharma Srl: lead

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cristina Capusa, PhD

  "Dr Carol Davila" University Hospital of Nephrology, Romania

  STUDY DIRECTOR

• Gabriel Mircescu, PhD

  "Dr Carol Davila" University Hospital of Nephrology, Romania

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 9, 2009
• Study Start: May 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: January 1, 2013
• Last Updated: June 26, 2019

Record last verified: 2013-03