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Add-on Pentoxifylline to Losartan Versus Increasing Dose of Losartan on NT-PRO BNP in Type 2 Diabetics With Nephropathy

Primary Purpose

Diabetic Nephropathies

Status

Completed

Phase

Phase 4

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Pentoxifylline

Losartan

About this trial

This is an interventional prevention trial for Diabetic Nephropathies

Eligibility Criteria

38 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age>30 and age<70, urinary albumin excretion (UAE) ≥150 mg/24 h

Exclusion Criteria:

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

Sites / Locations

Tehran University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

pentoxifylline & losartan

Losartan

Arm Description

pentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks.

losartan arm took 100mg losartan daily for 12 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Urinary albumin excretion

Urinary albumin excretion assessed by overnight (12 hour) collection of urine. Measured at baseline, 3rd month

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

estimated glomerular filtration rate

estimated glomerular filtration rate calculated using the formula developed by Chronic Kidney Disease Epidemiology Collaboration. Measured at baseline, 3rd month

serum creatinine concentrations

serum creatinine concentrations assessed by Jaffe method. Measured at baseline, 3rd month

Full Information

NCT ID

NCT03006952

First Posted

December 24, 2016

Last Updated

December 29, 2016

Sponsor

Tehran University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03006952

Brief Title

Add-on Pentoxifylline to Losartan Versus Increasing Dose of Losartan on NT-PRO BNP in Type 2 Diabetics With Nephropathy

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Nephropathies

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pentoxifylline & losartan

Arm Type

Active Comparator

Arm Description

pentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks.

Arm Title

Losartan

Arm Type

Active Comparator

Arm Description

losartan arm took 100mg losartan daily for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Pentoxifylline

Other Intervention Name(s)

oxpentifylline

Intervention Description

pentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Losartan

Other Intervention Name(s)

Cozaar

Intervention Description

losartan arm took 100mg losartan daily for 12 weeks.

Primary Outcome Measure Information:

Title

N terminal brain natriuretic peptide (NT-pro BNP)

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Highly sensitive C-reactive protein (hsCRP)

Description

Time Frame

3 months

Title

Urinary albumin excretion

Description

Urinary albumin excretion assessed by overnight (12 hour) collection of urine. Measured at baseline, 3rd month

Time Frame

3 months

Title

Blood pressure

Description

Time Frame

3 months

Title

estimated glomerular filtration rate

Description

estimated glomerular filtration rate calculated using the formula developed by Chronic Kidney Disease Epidemiology Collaboration. Measured at baseline, 3rd month

Time Frame

3 months

Title

serum creatinine concentrations

Description

serum creatinine concentrations assessed by Jaffe method. Measured at baseline, 3rd month

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

38 Years

Maximum Age & Unit of Time

76 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age>30 and age<70, urinary albumin excretion (UAE) ≥150 mg/24 h Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alireza Esteghamati, MD

Organizational Affiliation

Endocrinology and Metabolism Research Center (EMRC), Vali-Asr Hospital, Tehran University of Medical Sciences, Tehran, Iran

Official's Role

Study Chair

Facility Information:

Facility Name

Tehran University of Medical Sciences

City

Tehran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Add-on Pentoxifylline to Losartan Versus Increasing Dose of Losartan on NT-PRO BNP in Type 2 Diabetics With Nephropathy

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