Clinical Outcome of Vinpocetine in Diabetic Nephropathy
Recruiting
Phase 2Phase 3Interventional Study
Diabetic Kidney DiseaseDiabetic Nephropathies
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
64 (estimated)
Sponsor
Ain Shams University · Other
Who this trial is looking for
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The goal of this controlled, randomized, clinical trial is to evaluate the effect of vinpocetine on clinical outcomes on the diabetic nephropathy patients.
The following will be evaluated; anthropometrics, kidney functions, glucose panel, lipid panel, ICAM-1, quality of life.
Participants will receive either vinpocetine or placebo, twice daily for 3 months.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years,
* Type II diabetic patients with CKD stage 3 (eGFR = 30 - 59 ml/min) or stage 4 (eGFR 15-29 ml/min),
* Albumin/Creatinine ratio (ACR): 30 - 300 μg /mg (microalbuminuria),
* Stable standard therapy for at least three months prior to inclusion in the study.
Excl…
Inclusion Criteria:
* Age ≥ 18 years,
* Type II diabetic patients with CKD stage 3 (eGFR = 30 - 59 ml/min) or stage 4 (eGFR 15-29 ml/min),
* Albumin/Creatinine ratio (ACR): 30 - 300 μg /mg (microalbuminuria),
* Stable standard therapy for at least three months prior to inclusion in the study.
Exclusion Criteria:
* Kidney donor or recipient,
* Active malignancy,
* Pregnancy or breastfeeding,
* Known intolerance or hypersensitivity to VPN,
* Participation in other interventional trials,
* Patients with inadequate liver function (ALT and AST three times greater than the upper normal limits),
* Patients with severe comorbidities
* Patients receiving warfarin
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