L-Cysteine in Peritoneal Dialysis (CINDY)

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

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.

Study Overview

• Status: Completed
• Conditions: Uremia
• Intervention / Treatment: Other: Placebo; Dietary supplement: L-cysteine

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Bergamo
    • Ranica, Bergamo, Italy, 24020
      • Clinical Research Center for Rare Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Mario Negri Institute for Pharmacological Research
• Collaborators: Bio3 Research s.r.l. - Milan Italy

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: January 28, 2014
• First Submitted That Met QC Criteria: January 29, 2014
• First Posted (Estimate): January 30, 2014

Study Record Updates

• Last Update Posted (Estimate): June 30, 2015
• Last Update Submitted That Met QC Criteria: June 29, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Inflammation; Glomerular filtration rate; L-Cysteine; Peritoneal dialysis; Diuresis; Peritoneal function
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Uremia
• Other Study ID Numbers: CINDY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No