CINDY: L-Cysteine in Peritoneal Dialysis

Sponsor

Mario Negri Institute for Pharmacological Research (Other)

Overall Status

Completed

CT.gov ID

NCT02050139

Collaborator

Bio3 Research s.r.l. - Milan Italy (Other)

Enrollment

Location

Arms

15.9

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Uremia	Dietary Supplement: L-cysteine Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Supportive Care

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

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: L-cysteine (Biocysan®) Study subjects will take one tablet of L-cysteine or placebo every morning four times a week and two tablets of L-cysteine or placebo three times a week during the whole study period	Dietary Supplement: L-cysteine Other Names: Biocysan®
Placebo Comparator: Placebo Study subjects will take one tablet of L-cysteine or placebo every morning four times a week and two tablets of L-cysteine or placebo three times a week during the whole study period	Other: Placebo

Arm

Intervention/Treatment

Experimental: L-cysteine (Biocysan®)

Study subjects will take one tablet of L-cysteine or placebo every morning four times a week and two tablets of L-cysteine or placebo three times a week during the whole study period

Dietary Supplement: L-cysteine

Other Names:

Biocysan®

Placebo Comparator: Placebo

Study subjects will take one tablet of L-cysteine or placebo every morning four times a week and two tablets of L-cysteine or placebo three times a week during the whole study period

Other: Placebo

Outcome Measures

Primary Outcome Measures

24-hour urine output [Changes from Baseline at 1,2 and 3 month.]
Measured Glomerular Filtration Rate (GFR) [Changes from baseline at 1, 2 and 3 month.]

Secondary Outcome Measures

Office systolic, diastolic, pulse and mean blood pressure [Changes from Baseline at 1,2 and 3 month.]
Urinary albumin excretion. [Changes from Baseline at 1,2 and 3 month.]
2.27% Peritoneal Equilibration test (PET) [Changes from Baseline at 1,2 and 3 month.]
Pulse wave velocity (measured by tonometry) [Changes from Baseline at 1,2 and 3 month.]
Augmentation Index (measured by tonometry) [Changes from Baseline at 1,2 and 3 month.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.