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

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

Interventions

DRUG

pentoxifylline

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

Sponsors & Collaborators

• Centro de Investigación Biomédica de Michoacán.

  collaborator UNKNOWN

• Hospital General Regional N° 1 Instituto Mexicano del Seguro Social.

  collaborator UNKNOWN

• Hospital General de Zona N° 83 Instituto Mexicano del Seguro Social.

  collaborator UNKNOWN

• Coordinación Auxiliar Medica de Investigación en Salud. Delegación Michoacán.

  collaborator UNKNOWN

• Maria Eugenia Galván Plata

  lead OTHER_GOV

Principal Investigators

• Oliva Mejía-Rodríguez, PhD · CIBIMI IMSS

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-01

Primary Completion

2019-07-30

Completion

2021-12-31

Countries

• Mexico

Study Locations