Investigational and Comparative Study in the Management of Diabetic Nephropathy

NCT05487755 | Completed Phase 3

• 1 other identifier: DN mangement
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Nephropathy Type 2

Outcome Measures

Primary Outcomes (6)

• Change in Urinary albumin/creatinine ratio (ACR)

  Measurement of urine albumin to creatinne ratio by measurement of urine albumin using Turbidimetric immunoassay method and measurement of urine creatinnie by standard by enzymatic colorimetric methods

  Change between baseline and six months after

• Change in Hemoglobin A1c (HbA1c).

  Measurement of Hemoglobin A1C using (HPLC: ion exchange chromatography)

  Change between baseline and six months after

• Change in Fasting blood glucose.

  Measurement of Fasting blood glucose by using standard enzymatic colorimetric methods

  Change between baseline and six months after

• Change in Sr Cr

  Measurement of serum creatinine using colorimetric technique

  Change between baseline and six months after

• Change in Creatinine clearance

  Creatinine clearance was calculated by (Cockcroft-Gault Formula)

  Change between baseline and six months after

• change in 2- Hours Postprandial blood glucose

  Measurement 2- Hours Postprandial blood glucose in blood using standard enzymatic colorimetric methods

  Change between baseline and six months after

Secondary Outcomes (4)

• Change in serum ((TNF-α).

  Change between baseline and six months after

• Change in Urinary NGAL (uNGAL).

  Change between baseline and six months after

• Change in Lipid profile (TG, LDL, and HDL).

  Change between baseline and six months after

• Change in serum malondialdehyde (MDA) .

  Change between baseline and six months after

Study Arms (3)

control group

NO INTERVENTION

: (n=30) control group will receive traditional therapy blood glucose lowering agent +RAAS blockade ACEI or ARBs for six months.

Tadalafil group

EXPERIMENTAL

:( n=30) will receive traditional therapy +tadalafil PO 20 mg every other day for six months

Drug: Tadalafil 20Mg Oral Tablet

pentoxifylline group

EXPERIMENTAL

:( n=30) will receive traditional therapy+ pentoxifylline PO 400 mg twice daily for six months.

Drug: Pentoxifylline 400 MG Oral Tablet

Interventions

Tadalafil 20Mg Oral Tablet DRUG

Tadalafil is a phosphodiesterase type 5 enzyme (PDE5) inhibitor used mainly in erectile dysfunction and pulmonary hypertension by a mechanism involving increase(NO-cGMP-PKG) signaling pathway.(8) Tadalafil is a powerful pleiotropic drug that it can be used in DN as it can target more than pathway involved in pathogenesis of DN include hyperglycemia and endothelial dysfunction through increase (NO-cGMP) signaling pathway as well as hyperlipidemia

Also known as: cialong

Tadalafil group

Pentoxifylline 400 MG Oral Tablet DRUG

Pentoxifylline is a methyl xanthine derivative, non selective phosphodiesterase enzyme inhibitor used mainly to treat peripheral vascular diseases by improve blood flow

Also known as: Pental SR

pentoxifylline group

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A confirmed with clinical diagnosis of T2DM with duration at least 7 years to ensure established of micro-vascular complication (DKD).
• females (post-menopause), males with sufficient erectile function.
• Patients on stage 3 DN with evidence of persistent micro-albuminuria. All Abnormal tests of (UACR) must be confirmed in two out of three samples collected over a 6 month period before enrolled in the study.
• (urinary ACR≥30-300mg/g) in 3 consecutive measurements in 6 months period despite treatment with RAAS blockade(ramipril 10 mg ) ACEI or for at least 6 months period before enrollment in the study at maximum recommended tolerated dose.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of pharmacy

Tanta, Egypt

Location

Related Publications (3)

• Rivero A, Mora C, Muros M, Garcia J, Herrera H, Navarro-Gonzalez JF. Pathogenic perspectives for the role of inflammation in diabetic nephropathy. Clin Sci (Lond). 2009 Mar;116(6):479-92. doi: 10.1042/CS20080394.

  PMID: 19200057 BACKGROUND

• Wada J, Makino H. Inflammation and the pathogenesis of diabetic nephropathy. Clin Sci (Lond). 2013 Feb;124(3):139-52. doi: 10.1042/CS20120198.

  PMID: 23075333 BACKGROUND

• Hegazy SK, Amaar WA, Hegab WSM. Tadalafil versus pentoxifylline in the management of diabetic kidney disease: a randomized clinical trial. Diabetol Metab Syndr. 2024 Jun 24;16(1):138. doi: 10.1186/s13098-024-01363-3.

  PMID: 38915115 DERIVED

MeSH Terms

Interventions

Tadalafil; Tablets; Pentoxifylline

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Dosage Forms; Pharmaceutical Preparations; Theobromine; Xanthines; Purinones; Purines

Study Officials

• Wafaa S Hegab, Lecturer

  Tanta University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical pharmacist

Model Details: * This is a randomized, controlled, prospective study. * Ninety diabetic nephropathy patients at stage 3(micro-albuminuria) will be divided into three groups as follow -Group 1: (n=30) control group will receive traditional therapy blood glucose lowering agent +RAAS blockade ACEI or ARBs for six months. * Group 2 :( n=30) will receive traditional therapy +tadalafil PO 20 mg every other day for six months. Group 3 :( n=30) will receive traditional therapy+ pentoxifylline PO 400 mg twice daily for six months.

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: August 4, 2022
• Study Start: February 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

EG (1)