Investigational and Comparative Study in the Management of Diabetic Nephropathy

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to investigate and compare the safety and efficacy of selective (PDE5) enzyme inhibitor; tadalafil and non selective (PDE) inhibitor; pentoxifylline in diabetic nephropathy to improve glucose metabolism, lipid profile and decrease albuminuria.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tanta University
• Treatments: Pentoxifylline; Tadalafil

Criteria

Inclusion Criteria:Patients with clinical diagnosis of T2DM.

• Patients on stage 3 DN with evidence of persistent micro-albuminuria (urinary ACR≥30-300mg/g) in 3 consecutive measurements in 3 months period despite treatment with RAAS blockade ACEI or ARBs for at least 3 months period before enrollment in the study at maximum recommended tolerated dose.

Exclusion Criteria:

• Cardiovascular disease: angina, arrhythmias, myocardial Infarction, heart failure (NYHA II -IV), uncontrolled hypertension > (170 \100 mm Hg) severe hypotension < (90\50 mm Hg).

• Hearing problem, vision defect, thyroid disorders, alcohol abuse.

• Hepatic insufficiency (child -Pugh class C), (ALT or AST>3N), cholestasis.

• Known allergy to tadalafil or methylxanthine.

• Use alpha one blockers, medications strongly alter CYP3A4 inducer or inhibitor, use of nitrates, other PDEI drug.

• Bleeding disorders, peptic ulcer, and stroke.

• Pregnancy, lactation.

• Renal disease (acute kidney injury, recent exposure to radio- contrast media, creatinine clearance <30 mL /min.