Diabetic NephropathyPhase 2/3NCT00556465
Efficacy of N-Acetylcysteine in Treatment of Overt Diabetic Nephropathy
A Phase 2/3 study testing N-acetylcysteine in people with Diabetic Nephropathy and Chronic Kidney Disease, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
Diabetic nephropathy has become the single most frequent cause of end-stage renal disease. On a molecular level, at least five major pathways have been implicated in glucose-mediated vascular and renal damage and all of these could reflect a single hyperglycaemia-induced process of overproduction of reactive oxygen… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetic Nephropathy, Chronic Kidney Disease, Diabetes Type 2
- What is being tested?
- N-acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Jan 2007to Jun 2007
- Phase
- Phase 2/3
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic patients with more than 500 mg protein in 24 hours urine protein sample
- Males and post-menopausal non-lactating and non-pregnant females.
- Age greater than or equal to 30 years of age.
- Serum creatinine less than 3.0 mg/dL (265 micromoles per liter)
- Willing and able to give informed consent
Who cannot join
- Type 1 (insulin-dependent; juvenile onset) diabetes
- Patients with known non-diabetic renal disease
- Renal allograft
- Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 3 months of study entry
- Cerebrovascular accident within 3 months of study entry
- New York Heart Association Functional Class III or IV
- Known allergies or intolerance to N-acetylcysteine
- Untreated urinary tract infection or other medical condition that may impact urine protein values.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of N-Acetylcysteine for Treatment of Overt Diabetic Nephropathy
Diabetic nephropathy has become the single most frequent cause of end-stage renal disease.
On a molecular level, at least five major pathways have been implicated in glucose-mediated vascular and renal damage and all of these could reflect a single hyperglycaemia-induced process of overproduction of reactive oxygen species.
Read more
Recent studies have shown that inflammation, and more specifically pro-inflammatory cytokines play a determinant role in the development of micro- vascular diabetic complications, most of the attention has been focused on the implications of TNF-α in the setting of diabetic nephropathy.
Glutathione is the most abundant low-molecular-weight thiol, and Glutathione/ glutathione disulfide is the major redox couple in animal cells.
N-acetylcysteine is effective precursors of cysteine for tissue Glutathione synthesis.
Not only does N-acetylcysteine exhibit antioxidant properties, but it may also counteract the glycation cascade through the inhibition of oxidation.
N-acetylcysteine can also reduce the apoptosis elicited by reactive oxygen species .
Indeed, N-acetylcysteine has been shown to inhibit reactive oxygen species induced mesangial apoptosis and to be able to protect cells from glucose-induced inhibition of proliferation.
- Being tested
- N-acetylcysteine
- Keywords
- diabetic nephropathy, proteinuria, antioxidant
- Medical subject headings
- Diabetic Nephropathies, Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
600 mg of effervescent N-acetylcysteine tablet twice per day for three months
| Study group | Role | What they receive |
|---|---|---|
| A, 1,III | Experimental | in this arm patients took 1200 mg N-acetylcysteine Receives: Drug: N-acetylcysteine |
| B,2, III | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteinuria
Measured: 3 months
Secondary outcomes (1)
blood pressure,serum creatinine,GFR,c-reactive protein,
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 posted12 Nov 2007 (estimated)
- Study startJan 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- mohammad mahdi sagheb, MD, Study director, shiraz university of medical science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556465
- Sponsor's protocol ID
- 3046
- Status last verified
- Nov 2007
- First submitted
- 9 Nov 2007
- Last updated
- 12 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of N-Acetylcysteine for Treatment of Overt Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT00556465
- Acronym / sponsor ID
- 3046
- Keywords
- diabetic nephropathy, proteinuria, antioxidant
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Jun 2007 (actual)
- First posted
- 12 Nov 2007 (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.
Diabetic nephropathy has become the single most frequent cause of end-stage renal disease.
On a molecular level, at least five major pathways have been implicated in glucose-mediated vascular and renal damage and all of these could reflect a single hyperglycaemia-induced process of overproduction of reactive oxygen species.
Recent studies have shown that inflammation, and more specifically pro-inflammatory cytokines play a determinant role in the development of micro- vascular diabetic complications, most of the attention has been focused on the implications of TNF-α in the setting of diabetic nephropathy.
Glutathione is the most abundant low-molecular-weight thiol, and Glutathione/ glutathione disulfide is the major redox couple in animal cells.
N-acetylcysteine is effective precursors of cysteine for tissue Glutathione synthesis.
Not only does N-acetylcysteine exhibit antioxidant properties, but it may also counteract the glycation cascade through the inhibition of oxidation.
N-acetylcysteine can also reduce the apoptosis elicited by reactive oxygen species .
Indeed, N-acetylcysteine has been shown to inhibit reactive oxygen species induced mesangial apoptosis and to be able to protect cells from glucose-induced inhibition of proliferation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, 1,III | Experimental | Drug: N-acetylcysteinein this arm patients took 1200 mg N-acetylcysteine |
| B,2, III | No intervention | – |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetic patients with more than 500 mg protein in 24 hours urine protein sample
- Males and post-menopausal non-lactating and non-pregnant females.
- Age greater than or equal to 30 years of age.
- Serum creatinine less than 3.0 mg/dL (265 micromoles per liter)
- Willing and able to give informed consent
Key exclusion criteria (8 listed)
- Type 1 (insulin-dependent; juvenile onset) diabetes
- Patients with known non-diabetic renal disease
- Renal allograft
- Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 3 months of study entry
- Cerebrovascular accident within 3 months of study entry
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-acetylcysteine600 mg of effervescent N-acetylcysteine tablet twice per day for three months | Drug | A, 1,III |
Primary outcome
Proteinuria
Time frame: 3 months
1 secondary outcome
blood pressure,serum creatinine,GFR,c-reactive protein,
Time frame: 3 months
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 12 Nov 2007.
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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.
mohammad mahdi sagheb, MD study director
shiraz university of medical science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing N-acetylcysteine in people with Diabetic Nephropathy and Chronic Kidney Disease, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 5 inclusion and 8 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 12 Nov 2007. 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 Iran. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proteinuria (time frame: 3 months). 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 12 Nov 2007.