UremiaPhase 2CINDYNCT02050139
L-Cysteine in Peritoneal Dialysis
A Phase 2 study testing L-cysteine in people with Uremia, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uremia
- What is being tested?
- L-cysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2014to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- L-cysteine, Placebo
- Keywords
- L-Cysteine, Peritoneal dialysis, Diuresis, Glomerular filtration rate, Peritoneal function, Inflammation
- Medical subject headings
- Uremia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-cysteineDietary supplement
Also called Biocysan®
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour urine output
Measured: Changes from Baseline at 1,2 and 3 month.
Measured Glomerular Filtration Rate (GFR)
Measured: Changes from baseline at 1, 2 and 3 month.
Secondary outcomes (5)
Office systolic, diastolic, pulse and mean blood pressure
Measured: Changes from Baseline at 1,2 and 3 month.
Urinary albumin excretion.
Measured: Changes from Baseline at 1,2 and 3 month.
2.27% Peritoneal Equilibration test (PET)
Measured: Changes from Baseline at 1,2 and 3 month.
Pulse wave velocity (measured by tonometry)
Measured: Changes from Baseline at 1,2 and 3 month.
Augmentation Index (measured by tonometry)
Measured: Changes from Baseline at 1,2 and 3 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Sponsor type
- University, hospital or other
- Collaborators
- Bio3 Research s.r.l. - Milan Italy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050139
- Sponsor's protocol ID
- CINDY
- Acronym
- CINDY
- Status last verified
- Jun 2015
- First submitted
- 28 Jan 2014
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02050139
- Acronym / sponsor ID
- CINDY / CINDY
- Conditions
- Uremia
- Keywords
- L-Cysteine, Peritoneal dialysis, Diuresis, Glomerular filtration rate, Peritoneal function, Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- Bio3 Research s.r.l. - Milan Italy
- Study start
- Feb 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-cysteine (Biocysan®) | Experimental | Dietary Supplement: L-cysteineStudy 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 |
| Placebo | Placebo comparator | Other: PlaceboStudy 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-cysteineAlso: Biocysan® | Dietary supplement | L-cysteine (Biocysan®) |
| Placebo | Other | Placebo |
Primary outcome
24-hour urine output
Time frame: Changes from Baseline at 1,2 and 3 month.
Measured Glomerular Filtration Rate (GFR)
Time frame: Changes from baseline at 1, 2 and 3 month.
5 secondary outcomes
Office systolic, diastolic, pulse and mean blood pressure
Time frame: Changes from Baseline at 1,2 and 3 month.
Urinary albumin excretion.
Time frame: Changes from Baseline at 1,2 and 3 month.
2.27% Peritoneal Equilibration test (PET)
Time frame: Changes from Baseline at 1,2 and 3 month.
Pulse wave velocity (measured by tonometry)
Time frame: Changes from Baseline at 1,2 and 3 month.
Augmentation Index (measured by tonometry)
Time frame: Changes from Baseline at 1,2 and 3 month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-cysteine in people with Uremia, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour urine output (time frame: Changes from Baseline at 1,2 and 3 month.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2015.