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

NCT03006952 | Completed Phase 4 DMC

• 1 other identifier: 931133003
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Nephropathies

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (5)

• Highly sensitive C-reactive protein (hsCRP)

  3 months

• Urinary albumin excretion

  3 months

• Blood pressure

  3 months

• estimated glomerular filtration rate

  3 months

• serum creatinine concentrations

  3 months

Study Arms (2)

pentoxifylline & losartan

ACTIVE COMPARATOR

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

Drug: Pentoxifylline; Drug: Losartan

Losartan

ACTIVE COMPARATOR

losartan arm took 100mg losartan daily for 12 weeks.

Drug: Losartan

Interventions

Pentoxifylline DRUG

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

Also known as: oxpentifylline

pentoxifylline & losartan

Losartan DRUG

losartan arm took 100mg losartan daily for 12 weeks.

Also known as: Cozaar

Losartan; pentoxifylline & losartan

Eligibility Criteria

• Age: 38 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Tehran University of Medical Sciences

Tehran, Iran

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Pentoxifylline; Losartan

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Tetrazoles

Study Officials

• Alireza Esteghamati, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2016
• First Posted: December 30, 2016
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 30, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

IR (1)