L-Cysteine in Peritoneal Dialysis

Uremia Clinical Trial

— CINDY  

Official title:

A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, CROSS-OVER STUDY TO EVALUATE THE RENAL AND BIOHUMORAL EFFECTS OF L-CYSTEINE COMPARED TO PLACEBO IN STABLE PERITONEAL DIALYSIS PATIENTS WITH RESIDUAL DIURESIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050139
• Other study ID #: CINDY
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2014
• Last updated: June 29, 2015
• Start date: February 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Mario Negri Institute for Pharmacological Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

Over the last decades, peritoneal dialysis has grown worldwide to become one of the most common modalities of renal replacement therapy, particularly in developing or newly industrialized countries, such as India, China, Korea, Turkey, Malaysia, Mexico and Brazil. Peritoneal dialysis has been associated with an initial survival benefit compared to hemodialysis, although this advantage becomes less apparent over time, likely due to the progressive loss of residual renal function and the development of pathological alterations of peritoneum . Recent results suggest that an antioxidant therapy by N-acetyl-cysteine oral supplementation may improve residual renal function in peritoneal dialysis patients. This finding may have major clinical relevance, as preserving residual renal function in peritoneal dialysis patients has been associated with improved survival . Aim of the present randomized, double-blind, crossover study is to confirm the preliminary evidence of the beneficial effects of antioxidant agents on residual renal function by using the L-enantiomeric form of cysteine in 10 prevalent peritoneal dialysis patients with residual diuresis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and females aged = 18 years;

• Chronic automated peritoneal dialysis;

• Residual 24-hour diuresis = 100 ml with less than 30% changes over the three months preceding randomization;

• Written informed consent.

Exclusion Criteria:

• Chronic automated peritoneal dialysis therapy since less than three months;

• Diabetes mellitus;

• Acute peritonitis during the three months before enrollment;

• Concomitant treatment with other antioxidant agents (including N-acetyl-cysteine and vitamin C);

• Cystinuria;

• Pregnancy or breastfeeding;

• Childbearing potential without reliable contraceptive methods during the whole study period;

• Alcohol or drug (excluding tobacco) abuse;

• Inability to comply with the study procedures during the whole study period, legal incapacity;

• Cancer and any severe systemic disease or clinical condition that may jeopardize data interpretation or completion of the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Uremia

Intervention

Dietary Supplement:
• L-cysteine

Other:
• Placebo

Locations

Country	Name	City	State
Italy	Clinical Research Center for Rare Diseases	Ranica	Bergamo

Sponsors (2)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research	Bio3 Research s.r.l. - Milan Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour urine output		Changes from Baseline at 1,2 and 3 month.	No
Primary	Measured Glomerular Filtration Rate (GFR)		Changes from baseline at 1, 2 and 3 month.	No
Secondary	Office systolic, diastolic, pulse and mean blood pressure		Changes from Baseline at 1,2 and 3 month.	No
Secondary	Urinary albumin excretion.		Changes from Baseline at 1,2 and 3 month.	No
Secondary	2.27% Peritoneal Equilibration test (PET)		Changes from Baseline at 1,2 and 3 month.	No
Secondary	Pulse wave velocity (measured by tonometry)		Changes from Baseline at 1,2 and 3 month.	No
Secondary	Augmentation Index (measured by tonometry)		Changes from Baseline at 1,2 and 3 month.	No