Renal DiseasePhase 4NCT01614431
N Acetyl Cysteine for Cystinosis Patients
A Phase 4 study testing N acetyl cysteine in people with Renal Disease and Cystinosis, run by University of Sao Paulo.
Trial summary
This study intends to verify the interference of N acetyl cysteine in the progression of chronic kidney disease in patients with Nephropathic Cystinosis. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Renal Disease, Cystinosis
- What is being tested?
- N acetyl cysteine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to May 2012
- Phase
- Phase 4
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- cystinosis patients age under 18 years with good compliance to the treatment with Chronic Kidney Disease 1 to 4 according to KDOQI
Who cannot join
- patients with CKD stage 5
About this study
Official title: N Acetyl Cysteine Can Decrease the Progression of Renal Disease in Cystinosis Patients
This study intends to verify the interference of N acetyl cysteine in the progression of chronic kidney disease in patients with Nephropathic Cystinosis.
Read the detailed description
Patients with Nephropathic Cystinosis have an increased oxidative stress and go to end-stage renal disease, even when all steps of the treatment are done. Therefore, this study is conducted to verify the interference of the stress oxidative in the progression of the renal disease with the use of an oxidant drug, N acetyl cysteine (NAC). The investigators selected patients with good compliance of the treatment. In these patients the investigators evaluate the serum creatinine, creatinine clearance estimated by Schwartz Formula, cystatin C and a marker of oxidative stress, TBARS ( thiobarbituric acid substances). The variables are analyzed 6 months before the introduction of NAC and the three months after NAC.
- Conditions
- Renal Disease, Cystinosis
- Being tested
- N acetyl cysteine
- Keywords
- renal function, before and after N acetyl cysteine, Cystinosis patients
- Medical subject headings
- Kidney Diseases, Cystinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N acetyl cysteineDrug
Also called N acety cysteine
N acetyl cysteine to cystinosis patients with CKD stages 1 to 4
N acetyl cysteineDrug
N acetyl cysteine for cystinosis patients CKD stages 1 to 4
| Study group | Role | What they receive |
|---|---|---|
| N acetyl cysteine | Experimental | NAC will be given to cystinosis patients and we will observe the renal function status and a marker of oxidative stress (TBARS) Receives: Drug: N acetyl cysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
creatinine clearance
creatinine clearance will be evaluate 6 months beforw and at baseline and after 3 months with NAC
Measured: change in creatinine clearance evaluated 6 months before , at baseline and after 3 months with NAC
cystatin c
Cystinosis patients will be evaluated 6 months before and at baseline and after 3 months after the use of NAC
Measured: change in cystatin C from baseline and after 3 months with NAC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startMar 2011
- Primary completionJan 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Maria Helena Vaisbich, University of Sao Paulo
- Investigators
- Maria Helena Vaisbich, Doctor, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614431
- Sponsor's protocol ID
- Cystinosis and NAC
- Status last verified
- Jun 2012
- First submitted
- 19 May 2012
- Last updated
- 20 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N Acetyl Cysteine Can Decrease the Progression of Renal Disease in Cystinosis Patients
- ClinicalTrials.gov ID
- NCT01614431
- Acronym / sponsor ID
- Cystinosis and NAC
- Conditions
- Renal Disease, Cystinosis
- Keywords
- renal function, before and after N acetyl cysteine, Cystinosis patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Mar 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 8 Jun 2012 (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.
This study intends to verify the interference of N acetyl cysteine in the progression of chronic kidney disease in patients with Nephropathic Cystinosis.
Detailed description
Patients with Nephropathic Cystinosis have an increased oxidative stress and go to end-stage renal disease, even when all steps of the treatment are done. Therefore, this study is conducted to verify the interference of the stress oxidative in the progression of the renal disease with the use of an oxidant drug, N acetyl cysteine (NAC). The investigators selected patients with good compliance of the treatment. In these patients the investigators evaluate the serum creatinine, creatinine clearance estimated by Schwartz Formula, cystatin C and a marker of oxidative stress, TBARS ( thiobarbituric acid substances). The variables are analyzed 6 months before the introduction of NAC and the three months after NAC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N acetyl cysteine | Experimental | Drug: N acetyl cysteineNAC will be given to cystinosis patients and we will observe the renal function status and a marker of oxidative stress (TBARS) |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- cystinosis patients age under 18 years with good compliance to the treatment with Chronic Kidney Disease 1 to 4 according to KDOQI
Key exclusion criteria (1 listed)
- patients with CKD stage 5
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 acetyl cysteineAlso: N acety cysteineN acetyl cysteine to cystinosis patients with CKD stages 1 to 4 | Drug | N acetyl cysteine |
| N acetyl cysteineN acetyl cysteine for cystinosis patients CKD stages 1 to 4 | Drug | N acetyl cysteine |
Primary outcome
creatinine clearance
Time frame: change in creatinine clearance evaluated 6 months before , at baseline and after 3 months with NAC
creatinine clearance will be evaluate 6 months beforw and at baseline and after 3 months with NAC
cystatin c
Time frame: change in cystatin C from baseline and after 3 months with NAC
Cystinosis patients will be evaluated 6 months before and at baseline and after 3 months after the use of NAC
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 20 Jun 2012.
Related trials for Renal Disease
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
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.
Maria Helena Vaisbich, Doctor principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N acetyl cysteine in people with Renal Disease and Cystinosis, run by University of Sao Paulo.
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 1 inclusion and 1 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 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
creatinine clearance (time frame: change in creatinine clearance evaluated 6 months before , at baseline and after 3 months with NAC). 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 20 Jun 2012.