NCT06441591

Brief Summary

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 Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

July 10, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 11, 2024

Status Verified

July 1, 2024

Enrollment Period

11 months

First QC Date

May 27, 2024

Last Update Submit

July 10, 2024

Conditions

Diabetic Kidney DiseaseDiabetic Nephropathies

Keywords

VinpocetineDiabetic nephropathydiabetic kidney diseaseUACRICAM

Outcome Measures

Primary Outcomes (1)

  • level of Albuminuria

    assessment of the amount of albumin excreted in urine

    Samples will be measured at baseline and after 12 weeks

Secondary Outcomes (9)

  • Albumin: creatinine ratio (ACR)

    Samples will be measured at baseline and after 12 weeks

  • Serum Creatinine

    Samples will be measured at baseline and after 12 weeks

  • Blood urea nitrogen

    Samples will be measured at baseline and after 12 weeks

  • Hemoglobin A1c

    Samples will be measured at baseline and after 12 weeks

  • Fasting and postprandial blood glucose

    Samples will be measured at baseline and after 12 weeks

  • +4 more secondary outcomes

Study Arms (2)

Vinpocetine + Standard Therapy

EXPERIMENTAL

Vinpocetine capsules, 30 mg, twice daily, with meals for 3 months

Drug: VinpocetineDrug: Standard Therapy

Placebo + Standard Therapy

PLACEBO COMPARATOR

Placebo, twice daily, with meals for 3 months

Drug: Standard TherapyOther: Placebo

Interventions

VinpocetineDRUG

Vinca derivative of apovincamine, phosphodiestrase 1 inhibitor, sodium-gated voltage channel

Vinpocetine + Standard Therapy
Standard TherapyDRUG

Anti-hypertensive and anti-diabetic medications according to the the institution's protocol

Placebo + Standard TherapyVinpocetine + Standard Therapy
PlaceboOTHER

Starch-filled capsules, matching those of the intervention

Placebo + Standard Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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),

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ain Shams University Hospital

Cairo, Abbasseia, 11588, Egypt

NOT YET RECRUITING

Ain Shams Hospitals

Cairo, Abbasseya, 11588, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

vinpocetineStandard of Care

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Tamer El Said

CONTACT

201227366062drtamer_elsaid@med.asu.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 27, 2024

First Posted

June 4, 2024

Study Start

July 10, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

July 11, 2024

Record last verified: 2024-07

Locations

EG(2)