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Completed

NCT Number: NCT02050139

L-Cysteine in Peritoneal Dialysis

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.

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Key information

Conditions

Uremia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Research Center for Rare Diseases

Ranica, Bergamo, 24020, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L-Cysteine

Dietary Supplement

Other names: Biocysan®

Placebo

Other

Primary outcomes

  1. 24-hour urine output

    Time frame: Changes from Baseline at 1,2 and 3 month.

  2. Measured Glomerular Filtration Rate (GFR)

    Time frame: Changes from baseline at 1, 2 and 3 month.

Secondary outcomes

  1. Office systolic, diastolic, pulse and mean blood pressure

    Time frame: Changes from Baseline at 1,2 and 3 month.

  2. Urinary albumin excretion.

    Time frame: Changes from Baseline at 1,2 and 3 month.

  3. 2.27% Peritoneal Equilibration test (PET)

    Time frame: Changes from Baseline at 1,2 and 3 month.

  4. Pulse wave velocity (measured by tonometry)

    Time frame: Changes from Baseline at 1,2 and 3 month.

  5. Augmentation Index (measured by tonometry)

    Time frame: Changes from Baseline at 1,2 and 3 month.

Sponsors and collaborators

Lead sponsor

Mario Negri Institute for Pharmacological Research

Other

Collaborators

  • Bio3 Research s.r.l. - Milan Italy

Registry information

Official study 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

Acronym: CINDY

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 30, 2014
Registry last updated
Jun 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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