Renal TransplantationNACTXNCT00994305
Protective Effect of N-acetylcysteine on Early Outcomes of Deceased Renal Transplant
A study testing N-acetylcysteine in people with Renal Transplantation, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Investigate the therapeutic effects of the antioxidant N-acetylcysteine on early outcomes of deceased renal transplant patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- N-acetylcysteine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2005to Dec 2009
- Phase
- Interventional
- 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
- primary deceased renal transplant recipients
- adult (>18 yo)
Who cannot join
- unable to drink N-acetylcysteine during the first 7 PO
- participation in other study
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of Sao Paulo General Hospital Kidney Transplant Unit
São Paulo, São Paulo
About this study
Investigate the therapeutic effects of the antioxidant N-acetylcysteine on early outcomes of deceased renal transplant patients.
Read the detailed description
Investigate the therapeutic effects of 600 mg bid po of N-acetylcysteine on early outcomes of deceased renal transplant patients regarding oxidative stress and renal function.
Adult primary graft recipients of deceased renal donors will be randomly assign to treatment (NAC) or control group and prospectively evaluated for 90 days. Treatment group will receive N-acetylcysteine 600 mg bid po from 0 to 7th postoperative day (PO). Renal function will be determined by serum creatinine, Cockroft-Gault estimated GFR (eGFR) at 7th, 15th, 30th, 60th and 90th PO and dialysis free Kaplan-Meier estimate curve. Serum levels of thiobarbituric acid reactive substances (TBARS), which are markers of lipid peroxidation and oxidative stress, will be determined using the thiobarbituric acid assay from 0-7th PO. Statistical analysis will be performed using SPSS 16.0.
- Conditions
- Renal Transplantation
- Being tested
- N-acetylcysteine, control
- Keywords
- kidney transplantation, oxidative stress, acetylcysteine, graft rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
Also called Fluimucil
600 mg bid po 0-7 PO
controlDrug
Also called N/A (not applicable)
No treatment: standard care provided. No N-acetylcysteine administration.
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Active comparator | N-acetylcysteine 600 mg bid po 0-7 PO Receives: Drug: N-acetylcysteine |
| control | Sham comparator | No treatment: standard care provided. No N-acetylcysteine administration. Receives: Drug: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress: measure of the oxidative stress generated after the deceased renal transplant by laboratorial serum measure of Thiobarbituric Acid Reactive Substances (TBARS) with the Trichloroacetic acid method.
Measured: 7 days
Secondary outcomes (3)
Graft function: measure of serum creatinine
Measured: 3 months
Graft function:estimated creatinine clearance by Cokcroft-Gault formula
Measured: 3 months
Graft function: dialysis free status by Kaplan-Meier actuarial curve of recipients free from dialysis after deceased renal transplant
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startApr 2005
- Primary completionJun 2008
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Alexandre Danilovic, MD, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994305
- Sponsor's protocol ID
- NACTX
- Other IDs
- FAPESP 06/52046-0, CAPPesq 076/05
- Acronym
- NACTX
- Status last verified
- Oct 2009
- First submitted
- 9 Oct 2009
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Danilovic A, Lucon AM, Seguro AC, Shimizu MHM, Ianhez LE, Nahas WC, Srougi M. N-acetylcysteine attenuates oxidative stress in deceased renal transplantation. The Journal of Urology 181 (4): 740; 2009.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effect of N-acetylcysteine on Early Outcomes of Deceased Renal Transplant
- ClinicalTrials.gov ID
- NCT00994305
- Acronym / sponsor ID
- NACTX / NACTX
- Conditions
- Renal Transplantation
- Keywords
- kidney transplantation, oxidative stress, acetylcysteine, graft rejection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Apr 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2009 (estimated)
- First posted
- 14 Oct 2009 (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.
Investigate the therapeutic effects of the antioxidant N-acetylcysteine on early outcomes of deceased renal transplant patients.
Detailed description
Investigate the therapeutic effects of 600 mg bid po of N-acetylcysteine on early outcomes of deceased renal transplant patients regarding oxidative stress and renal function.
Adult primary graft recipients of deceased renal donors will be randomly assign to treatment (NAC) or control group and prospectively evaluated for 90 days. Treatment group will receive N-acetylcysteine 600 mg bid po from 0 to 7th postoperative day (PO). Renal function will be determined by serum creatinine, Cockroft-Gault estimated GFR (eGFR) at 7th, 15th, 30th, 60th and 90th PO and dialysis free Kaplan-Meier estimate curve. Serum levels of thiobarbituric acid reactive substances (TBARS), which are markers of lipid peroxidation and oxidative stress, will be determined using the thiobarbituric acid assay from 0-7th PO. Statistical analysis will be performed using SPSS 16.0.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Active comparator | Drug: N-acetylcysteineN-acetylcysteine 600 mg bid po 0-7 PO |
| control | Sham comparator | Drug: controlNo treatment: standard care provided. No N-acetylcysteine administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary deceased renal transplant recipients
- adult (>18 yo)
Key exclusion criteria (2 listed)
- unable to drink N-acetylcysteine during the first 7 PO
- participation in other study
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 |
|---|---|---|
| N-acetylcysteineAlso: Fluimucil600 mg bid po 0-7 PO | Drug | N-acetylcysteine |
| controlAlso: N/A (not applicable)No treatment: standard care provided. No N-acetylcysteine administration. | Drug | control |
Primary outcome
Oxidative stress: measure of the oxidative stress generated after the deceased renal transplant by laboratorial serum measure of Thiobarbituric Acid Reactive Substances (TBARS) with the Trichloroacetic acid method.
Time frame: 7 days
3 secondary outcomes
Graft function: measure of serum creatinine
Time frame: 3 months
Graft function:estimated creatinine clearance by Cokcroft-Gault formula
Time frame: 3 months
Graft function: dialysis free status by Kaplan-Meier actuarial curve of recipients free from dialysis after deceased renal transplant
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
- Results publicationDanilovic A, Lucon AM, Seguro AC, Shimizu MHM, Ianhez LE, Nahas WC, Srougi M. N-acetylcysteine attenuates oxidative stress in deceased renal transplantation. The Journal of Urology 181 (4): 740; 2009.
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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.
Alexandre Danilovic, MD principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-acetylcysteine in people with Renal Transplantation, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Oct 2009. 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 Brazil. 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.
Are results available for this study?
Results are not available in the source record.
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?
Oxidative stress: measure of the oxidative stress generated after the deceased renal transplant by laboratorial serum measure of Thiobarbituric Acid Reactive Substances (TBARS) with the Trichloroacetic acid method. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00994305, which also lists 1 linked publication.
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 14 Oct 2009.