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L-Cysteine in Peritoneal Dialysis (CINDY)

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ClinicalTrials.gov Identifier: NCT02050139
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : June 30, 2015
Sponsor:
Collaborator:
Bio3 Research s.r.l. - Milan Italy
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

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

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Study Type : Interventional  (Clinical Trial)
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 : February 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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 Name: 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



Primary Outcome Measures :
  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 Outcome Measures :
  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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050139


Locations
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Italy
Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy, 24020
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Bio3 Research s.r.l. - Milan Italy

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Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT02050139     History of Changes
Other Study ID Numbers: CINDY
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: June 2015

Keywords provided by Mario Negri Institute for Pharmacological Research:
L-Cysteine
Peritoneal dialysis
Diuresis
Glomerular filtration rate
Peritoneal function
Inflammation