Diabetic NephropathiesPhase 4NCT03006952
Add-on Pentoxifylline to Losartan Versus Increasing Dose of Losartan on NT-PRO BNP in Type 2 Diabetics With Nephropathy
A Phase 4 study testing Pentoxifylline and Losartan in people with Diabetic Nephropathies, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
This study was designed to assess the efficacy of adding pentoxifylline to losartan in comparison with increasing dose of losartan in type 2 diabetes patients with nephropathy. also the effect of pentoxifylline on N terminal brain natriuretic peptide (NT-pro BNP) and C-reactive protein Read more about this study
- Who is it for?
- Ages 38 to 76 years
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- Pentoxifylline and Losartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteIran
- Study dates
- Apr 2015to Sep 2015
- 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 38 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age>30 and age<70, urinary albumin excretion (UAE) ≥150 mg/24 h
Who cannot join
- any infectious or malignant diseases, non-diabetic kidney disease, retinal hemorrhage, acute myocardial infarction, uncontrolled hypertension, pregnancy, unable to follow up, hyperthyroidism, baseline serum potassium concentrations ≥5.5 meq/L, glomerular filtration rate (GFR)<30mL/min/1.73 m and intolerance of pentoxifylline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of add-on Pentoxifylline to Losartan Versus Increasing Dose of Losartan on Serum NT-PRO BNP and Proteinuria in Type 2 Diabetics With Nephropathy
This study was designed to assess the efficacy of adding pentoxifylline to losartan in comparison with increasing dose of losartan in type 2 diabetes patients with nephropathy. also the effect of pentoxifylline on N terminal brain natriuretic peptide (NT-pro BNP) and C-reactive protein
Read the detailed description
Addition of pentoxifylline to losartan provides antiproteinuric effects in type 2 diabetes patients with nephropathy that might relate to its effect on N terminal brain natriuretic peptide (NT-pro BNP) and C-reactive protein.
Pentoxifylline is a phosphodiestrase inhibitor with anti-inflammatory effects that was used in type 2 diabetes patients with nephropathy for treatment of diabetes complications.
NT-Pro BNP, which is released from the heart due to wall stress and pressures, is known as a diagnostic and prognostic marker for heart failure and cardiovascular mortality in type 2 diabetes.
- Conditions
- Diabetic Nephropathies
- Being tested
- Pentoxifylline, Losartan
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineDrug
Also called oxpentifylline
pentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks.
LosartanDrug
Also called Cozaar
losartan arm took 100mg losartan daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| pentoxifylline & losartan | Active comparator | pentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks. Receives: Drug: Pentoxifylline; Drug: Losartan |
| Losartan | Active comparator | losartan arm took 100mg losartan daily for 12 weeks. Receives: Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
N terminal brain natriuretic peptide (NT-pro BNP)
N terminal brain natriuretic peptide assessed using ELISA method (zelbio, Germany) with inter- and intra-assay coefficient of variation (CV) <12% and <10%. Measured at baseline, 3rd month
Measured: 3 months
Secondary outcomes (5)
Highly sensitive C-reactive protein (hsCRP)
Highly sensitive C-reactive protein assessed by commercial kits (DRG kit, Germany) using the ELISA (enzyme-linked immunosorbent assay) method with inter- and intra-assay coefficient of variation (CV) of <20%. Measured at baseline, 3rd month
Measured: 3 months
Urinary albumin excretion
Urinary albumin excretion assessed by overnight (12 hour) collection of urine. Measured at baseline, 3rd month
Measured: 3 months
Blood pressure
Systolic and diastolic blood pressure assessed by mercury sphygnomanometry. Patients were placed in a sitting position and after ten minutes rest, two readings from right-side hand with five minutes interval were obtained. Measured at baseline, 3rd month
Measured: 3 months
estimated glomerular filtration rate
estimated glomerular filtration rate calculated using the formula developed by Chronic Kidney Disease Epidemiology Collaboration. Measured at baseline, 3rd month
Measured: 3 months
serum creatinine concentrations
serum creatinine concentrations assessed by Jaffe method. Measured at baseline, 3rd month
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 posted30 Dec 2016 (estimated)
- Study startApr 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alireza Esteghamati, MD, Study chair, Endocrinology and Metabolism Research Center (EMRC), Vali-Asr Hospital, Tehran University of Medical Sciences, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006952
- Sponsor's protocol ID
- 931133003
- Status last verified
- Dec 2016
- First submitted
- 24 Dec 2016
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of add-on Pentoxifylline to Losartan Versus Increasing Dose of Losartan on Serum NT-PRO BNP and Proteinuria in Type 2 Diabetics With Nephropathy
- ClinicalTrials.gov ID
- NCT03006952
- Acronym / sponsor ID
- 931133003
- Conditions
- Diabetic Nephropathies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 30 Dec 2016 (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 was designed to assess the efficacy of adding pentoxifylline to losartan in comparison with increasing dose of losartan in type 2 diabetes patients with nephropathy. also the effect of pentoxifylline on N terminal brain natriuretic peptide (NT-pro BNP) and C-reactive protein
Detailed description
Addition of pentoxifylline to losartan provides antiproteinuric effects in type 2 diabetes patients with nephropathy that might relate to its effect on N terminal brain natriuretic peptide (NT-pro BNP) and C-reactive protein.
Pentoxifylline is a phosphodiestrase inhibitor with anti-inflammatory effects that was used in type 2 diabetes patients with nephropathy for treatment of diabetes complications.
NT-Pro BNP, which is released from the heart due to wall stress and pressures, is known as a diagnostic and prognostic marker for heart failure and cardiovascular mortality in type 2 diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pentoxifylline & losartan | Active comparator | Drug: Pentoxifylline, Drug: Losartanpentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks. |
| Losartan | Active comparator | Drug: Losartanlosartan arm took 100mg losartan daily for 12 weeks. |
Who may qualify
- Ages
- 38 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age>30 and age<70, urinary albumin excretion (UAE) ≥150 mg/24 h
Key exclusion criteria (1 listed)
- any infectious or malignant diseases, non-diabetic kidney disease, retinal hemorrhage, acute myocardial infarction, uncontrolled hypertension, pregnancy, unable to follow up, hyperthyroidism, baseline serum potassium concentrations ≥5.5 meq/L, glomerular filtration rate (GFR)<30mL/min/1.73 m and intolerance of pentoxifylline
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 |
|---|---|---|
| PentoxifyllineAlso: oxpentifyllinepentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks. | Drug | pentoxifylline & losartan |
| LosartanAlso: Cozaarlosartan arm took 100mg losartan daily for 12 weeks. | Drug | Losartan, pentoxifylline & losartan |
Primary outcome
N terminal brain natriuretic peptide (NT-pro BNP)
Time frame: 3 months
N terminal brain natriuretic peptide assessed using ELISA method (zelbio, Germany) with inter- and intra-assay coefficient of variation (CV) <12% and <10%. Measured at baseline, 3rd month
5 secondary outcomes
Highly sensitive C-reactive protein (hsCRP)
Time frame: 3 months
Urinary albumin excretion
Time frame: 3 months
Blood pressure
Time frame: 3 months
estimated glomerular filtration rate
Time frame: 3 months
serum creatinine concentrations
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 30 Dec 2016.
- Individual participant dataSharing planned: Yes
Related trials for Diabetic Nephropathies
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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.
Alireza Esteghamati, MD study chair
Endocrinology and Metabolism Research Center (EMRC), Vali-Asr Hospital, Tehran University of Medical Sciences, Tehran, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pentoxifylline and Losartan in people with Diabetic Nephropathies, run by Tehran 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 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 30 Dec 2016. 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 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?
N terminal brain natriuretic peptide (NT-pro BNP) (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 30 Dec 2016.