Pentoxifylline Effect in Patients With Diabetic Nephropathy.(PENFOSIDINE STUDY)

NCT03664414 | Unknown Phase 4 DMC

• 1 other identifier: CNIC-2015-785-065
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

One of the purposes of the management of the patient with chronic kidney disease (CKD)is to slow the decline of renal function. The mechanisms by which the renal function declines involve inflammatory and fibrotic responses due in part by the effects of oxidative stress. Pentoxifylline (PTX)is a drug that stimulates adenosine receptors, and produces inhibition of phosphodiesterases, as well as being a dopaminergic modulator through D1 and D2 receptors. Its main effects are inhibition of the inflammatory state by decreasing serum levels of tumor necrosis factor alpha (TNF-ɒ) and monocyte chemo attractant protein 1 (MCP\_1), which may slow down the decline of renal function. It also produces diminish of sympathetic activity, with the reduction of circulating levels of norepinephrine (NA), which may contribute to the reduction of glomerulosclerosis in diabetic patients. In the connective tissue increases the activity of the collagenases and decrease of collagen, fibronectin and glucosamine of the fibroblasts as well as inhibition of oxygen free radicals. Due to its antioxidant, anti-inflammatory and anti-fibrotic effects, PTX can result in an excellent therapeutic option for the prevention of CKD in DM2. This work proposes the use of pentoxifylline as treatment CKD in DM2. Its application in patients with CKD will allow a therapeutic management with different targets, for its antioxidant, anti-inflammatory and antifibrotic effects that will be evaluated by means of fibrosis, inflammation and oxidative stress markers. The results will be of great importance in clinical practice, since they will justify the use of a new pharmacological tool, already known, with minimal adverse effects and low cost, accessible to all strata of the population since it is found as generic.

Conditions

Chronic Kidney Disease stage3 and 4; Type 2 Diabetes Mellitus

Keywords

oxidative stress; fibrosis; inflammation; quality of life

Outcome Measures

Primary Outcomes (1)

• Change in the glomerular filtration rate

  It will be measure as to duplicate serum creatinine levels from baseline (mg/dL), or to pass from a stage of chronic kidney disease to he next stage (GFR mL/min)

  The measurements will be done baseline and every six months up to 24 months.

Secondary Outcomes (4)

• Change in oxidative stress marker.

  Change is assessed baseline, 6 months, 12 months, 18 months and 24 months.

• Change in fibrosis markers.

  Change is assessed baseline, 6 months, 12 months, 18 months and 24 months.

• Change in inflammation markers.

  Change is assessed baseline, 6 months, 12 months, 18 months and 24 months.

• Change in health-related quality of life

  The questionnaire will be applied baseline and every six months up to 24 months.

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Placebo group will receive 1 tablet of cellulose pill to mimic pentoxifylline tablets three times a day with meals, during the following two years.

Drug: pentoxifylline

Pentoxifylline group

ACTIVE COMPARATOR

Pentoxifillyne or experimental group will receive 400 mg of pentoxifylline three times a day with meals, during the following two years.

Drug: pentoxifylline

Interventions

pentoxifylline DRUG

Pentoxifylline or placebo will be prescribed three times a day with meals. All the participants will continue with the usual treatment. Time frame: two years

Also known as: Trental

Pentoxifylline group; Placebo group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CKD
• Type 2 diabetes mellitus
• Microalbuminuria
• Proteinuria.
• Creatinine plasma clearance ˂ of 60 mL / min.

You may not qualify if:

• History of psychiatric disorders,
• Immunosuppressants treatment
• Herbalism Treatment
• History of chronic alcoholism.
• Type 1 diabetes mellitus.
• Chronic obstructive pulmonary disease.
• Pulmonary fibrosis
• Heart failure
• HIV-AIDS.
• Liver cirrhosis.
• Chronic hepatitis.

Sponsors & Collaborators

• Maria Eugenia Galván Plata: lead
• Centro de Investigación Biomédica de Michoacán.: collaborator
• Hospital General Regional N° 1 Instituto Mexicano del Seguro Social.: collaborator
• Hospital General de Zona N° 83 Instituto Mexicano del Seguro Social.: collaborator
• Coordinación Auxiliar Medica de Investigación en Salud. Delegación Michoacán.: collaborator

Study Sites (1)

Cibimi - Hgz 83 Imss

Morelia, Michoacán, 58290, Mexico

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Fibrosis; Inflammation

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Oliva Mejía-Rodríguez, PhD

  CIBIMI IMSS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Eugenia Galván Plata, M. D

CONTACT

+015556276900; eugenia.galvan@imss.gob.mx

Carla A Carla Martínez Castuera Gómez, MD

CONTACT

+015556276900; carla.martinez@imss.gob.mx

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Plaebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinacion de Investigacion en Salud, México

Model Details: blinded,multicenter, randomized, pentoxifylline vs placebo controlled clinical trial. Time: two years after the enrollment of the last patient.

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: September 10, 2018
• Study Start: March 1, 2018
• Primary Completion: July 30, 2019
• Study Completion: December 31, 2021
• Last Updated: February 7, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available six months after the end of the study
• Access Criteria: Data access request will be reviewed by the research institutional board.

Locations

ME (1)