L-Cysteine in Peritoneal Dialysis

NCT02050139 | Completed Phase 2

• 1 other identifier: CINDY
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Uremia

Keywords

L-Cysteine; Peritoneal dialysis; Diuresis; Glomerular filtration rate; Peritoneal function; Inflammation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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.

Study Arms (2)

L-cysteine (Biocysan®)

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

L-cysteine DIETARY_SUPPLEMENT

Also known as: Biocysan®

L-cysteine (Biocysan®)

Placebo OTHER

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Clinical Research Center for Rare Diseases

Ranica, Bergamo, 24020, Italy

Location

MeSH Terms

Conditions

Uremia; Inflammation

Interventions

Cysteine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Sulfhydryl Compounds; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: January 30, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 30, 2015

Record last verified: 2015-06

Locations

IT (1)