L-Cysteine in Peritoneal Dialysis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02050139

Acronym

CINDY

Enrollment

Registered

2014-01-30

Start date

2014-02-28

Completion date

2015-06-30

Last updated

2015-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uremia

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTL-cysteine

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026