Diabetic NephropathyPhase 2/3NCT00663949
Assessment of the Effect of Captopril Versus Combination of Captopril and Pentoxifylline on Reducing Proteinuria in Type 2 Diabetic Nephropathy
A Phase 2/3 study testing Captopril and Captopril + Pentoxifylline in people with Diabetic Nephropathy, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
Diabetic nephropathy is the most common cause of ESRD and has a great impact on mortality and morbidity of diabetic patients. Despite renoprotective effect of ACE inhibitors in diabetic patients they can not hinder the progression of renal disease completely. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- Captopril and Captopril + Pentoxifylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIran
- Study dates
- Feb 2006to Jan 2008
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Absence of kidney or urinary tract disease
- Absence of high blood pressure OR Controlled blood pressure (≤140/90) with medication other than ACE inhibitors and/or non dihydropyridine calcium channel blockers
- A well controlled blood sugar level (HbA1c≤7.5%)
- Adhering to the diet protocol for patients with renal disease
Who cannot join
- NYHA functional class III, IV
- Valvular heart disease
- Unstable angina, myocardial infarction, cerebrovascular accidents
- Psychiatric disease
- Prior allograft kidney transplant
- Acute illness
Show all 14Show fewer
- Infectious disease including urinary tract infection
- Leukocytosis or any febrile illness at enrollment
- Prior history or development of any form of malignancy
- History of alcohol or drug abuse or smoking
- Pregnancy
- Need for surgery during the study
- Allergy to derivatives of methyl xanthines
- Current Pentoxyphilline use
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shiraz University of Medical Sciences ,Nemazee and Faghihi Hospital
Shiraz, Fars, 0098
About this study
Official title: Phase 2 Trial of Effect of Combine Pentoxifylline and Captopril on Proteinuria in Diabetic Nephropathy
Diabetic nephropathy is the most common cause of ESRD and has a great impact on mortality and morbidity of diabetic patients. Despite renoprotective effect of ACE inhibitors in diabetic patients they can not hinder the progression of renal disease completely. Pentoxifylline as a TNFa blocker may hinder progression of diabetic nephropathy in combination of captopril.
Read the detailed description
Diabetic nephropathy is the most common cause of ESRD and has a great impact on mortality and morbidity of diabetic patients. Despite renoprotective effect of ACE inhibitors in diabetic patients they can not hinder the progression of renal disease completely. TNFa is a cytokine that is a target for medical therapy in diabetic nephropathy. In this study the effect of captopril on overt diabetic nephropathy compared to effect of combination of captopril and an antiTNFa drug ( pentoxifylline).
- Conditions
- Diabetic Nephropathy
- Being tested
- Captopril, Captopril + Pentoxifylline
- Keywords
- diabetes, proteinuria, pentoxifylline
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaptoprilDrug
25 mg captopril tablet q8h
Captopril + PentoxifyllineDrug
patients takes captopril tablets 25 mg q8h and pentoxifylline 400 mg q8h
| Study group | Role | What they receive |
|---|---|---|
| A,1,II | Active comparator | patients in this arm takes 25 mg captopril q8h Receives: Drug: Captopril |
| A,2,II | Active comparator | Not described Receives: Drug: Captopril + Pentoxifylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
decreasing urinary protein
Measured: 2 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startFeb 2006
- Primary completionDec 2007
- Study completionJan 2008
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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Jamshid Roozbeh, MD, Study chair, sumsmohammad ghezloo, MD, Study director, SUMSmohammad mahdi sagheb, MD, Principal investigator, SUMSAmin Banihashemi, Principal investigator, SUMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663949
- Sponsor's protocol ID
- 3079
- Status last verified
- Mar 2008
- First submitted
- 21 Apr 2008
- Last updated
- 22 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of Effect of Combine Pentoxifylline and Captopril on Proteinuria in Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT00663949
- Acronym / sponsor ID
- 3079
- Conditions
- Diabetic Nephropathy
- Keywords
- diabetes, proteinuria, pentoxifylline
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 22 Apr 2008 (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 is the most common cause of ESRD and has a great impact on mortality and morbidity of diabetic patients. Despite renoprotective effect of ACE inhibitors in diabetic patients they can not hinder the progression of renal disease completely. Pentoxifylline as a TNFa blocker may hinder progression of diabetic nephropathy in combination of captopril.
Detailed description
Diabetic nephropathy is the most common cause of ESRD and has a great impact on mortality and morbidity of diabetic patients. Despite renoprotective effect of ACE inhibitors in diabetic patients they can not hinder the progression of renal disease completely. TNFa is a cytokine that is a target for medical therapy in diabetic nephropathy. In this study the effect of captopril on overt diabetic nephropathy compared to effect of combination of captopril and an antiTNFa drug ( pentoxifylline).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A,1,II | Active comparator | Drug: Captoprilpatients in this arm takes 25 mg captopril q8h |
| A,2,II | Active comparator | Drug: Captopril + Pentoxifylline |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Absence of kidney or urinary tract disease
- Absence of high blood pressure OR Controlled blood pressure (≤140/90) with medication other than ACE inhibitors and/or non dihydropyridine calcium channel blockers
- A well controlled blood sugar level (HbA1c≤7.5%)
- Adhering to the diet protocol for patients with renal disease
Key exclusion criteria (14 listed)
- NYHA functional class III, IV
- Valvular heart disease
- Unstable angina, myocardial infarction, cerebrovascular accidents
- Psychiatric disease
- Prior allograft kidney transplant
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 |
|---|---|---|
| Captopril25 mg captopril tablet q8h | Drug | A,1,II |
| Captopril + Pentoxifyllinepatients takes captopril tablets 25 mg q8h and pentoxifylline 400 mg q8h | Drug | A,2,II |
Primary outcome
decreasing urinary protein
Time frame: 2 and 6 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 22 Apr 2008.
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Diabetic Nephropathy, Diabetes Mellitus
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Pentoxifylline in Diabetic Kidney Disease
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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.
Jamshid Roozbeh, MD study chair
sums
mohammad ghezloo, MD study director
SUMS
mohammad mahdi sagheb, MD principal investigator
SUMS
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 Captopril and Captopril + Pentoxifylline in people with Diabetic Nephropathy, 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 4 inclusion and 14 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 22 Apr 2008. 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?
decreasing urinary protein (time frame: 2 and 6 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 22 Apr 2008.