Clinical Outcome of Vinpocetine in Diabetic Nephropathy
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAin Shams University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Kidney donor or recipient,
Active malignancy,
Pregnancy or breastfeeding,
Known intolerance or hypersensitivity to VPN,
Trial design
Design model
Parallel
Treatments tested in this trial
Vinpocetine
DrugVinca derivative of apovincamine, phosphodiestrase 1 inhibitor, sodium-gated voltage channel
Standard Therapy
DrugAnti-hypertensive and anti-diabetic medications according to the the institution's protocol
Placebo
Other interventionStarch-filled capsules, matching those of the intervention
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Vinpocetine + Standard TherapyExperimental treatment 2 interventions
Group B: Placebo + Standard TherapyPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
level of Albuminuria
assessment of the amount of albumin excreted in urine
Time frame
Samples will be measured at baseline and after 12 weeksSecondary outcomes
1
Albumin: creatinine ratio (ACR)
The urine ACR is calculated by dividing the urine albumin concentration by the urine creatinine concentration to account for differences in urine volume and more closely approximate the gold standard, 24-hour urine albumin excretion.
Time frame
Samples will be measured at baseline and after 12 weeks2
Serum Creatinine
assessment of the serum level of creatinine
Time frame
Samples will be measured at baseline and after 12 weeks3
Blood urea nitrogen
assessment of the level of blood urea nitrogen in serum
Time frame
Samples will be measured at baseline and after 12 weeks4
Hemoglobin A1c
assessment of the level of glycated hemoglobin
Time frame
Samples will be measured at baseline and after 12 weeksSponsors and contacts
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Source ClinicalTrials.gov