Clinical trial NCT02050139: L-Cysteine in Peritoneal Dialysis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uremia
Keywords: L-Cysteine
Peritoneal dialysis
Diuresis
Glomerular filtration rate
Peritoneal function
Inflammation
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
Collaborators: name: Bio3 Research s.r.l. - Milan Italy
First posted: 2014-01-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: 24-hour urine output
timeFrame: Changes from Baseline at 1,2 and 3 month.
measure: Measured Glomerular Filtration Rate (GFR)
timeFrame: Changes from baseline at 1, 2 and 3 month.
Secondary outcomes:
measure: Office systolic, diastolic, pulse and mean blood pressure
timeFrame: Changes from Baseline at 1,2 and 3 month.
measure: Urinary albumin excretion.
timeFrame: Changes from Baseline at 1,2 and 3 month.
measure: 2.27% Peritoneal Equilibration test (PET)
timeFrame: Changes from Baseline at 1,2 and 3 month.
measure: Pulse wave velocity (measured by tonometry)
timeFrame: Changes from Baseline at 1,2 and 3 month.
measure: Augmentation Index (measured by tonometry)
timeFrame: Changes from Baseline at 1,2 and 3 month.
Other outcomes:
Locations:
city: Ranica
country: Italy
facility: Clinical Research Center for Rare Diseases
state: Bergamo
Study officials:
References: