Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury

Phase 2

Terminated

• Conditions: Kidney Injury; Proteinuria; Hypertension
• Interventions: Drug: Placebo oral tablet; Drug: Isosorbide Mononitrate

• Registration Number: NCT04051957
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

The purpose of this study is to test the hypothesis that isosorbide mononitrate prevents deterioration of renal function in patients receiving anti-angiogenic therapies that target vascular endothelial growth factor (VEGF).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-09
• Study Start: 2019-09-26
• Primary Completion: 2021-02-12
• Study Completion: 2021-02-12
• Disposition First Submitted: 2021-06-23
• Results First Submitted: 2022-06-30
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-02
• Disposition First Submitted QC: 2022-08-02
• Last Update Submitted: 2022-08-02
• Results First Posted: 2022-08-03
• Disposition First Posted: 2022-08-03
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Patients on or enrolled for anti-VEGF therapy
• new-onset proteinuria, defined as a urine protein: creatinine ratio (UPC) of >500mg/g or hypertension (Systolic BP ≥ 140 mm Hg and/or diastolic BP ≥ 90 mm Hg) or a decrease in eGFR by ≥ 25% from baseline before starting therapy.

Exclusion Criteria

• Pregnant women
• Breast-feeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo oral tablet	-
Isosorbide Mononitrate	Isosorbide Mononitrate	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment	Baseline, Month 3
Number of Participants With a Reduction in Urine Protein Creatinine Ratio (UPC) of > 500 mg/Day From That Measured Before Enrollment	Baseline, Month 1

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment	Baseline, Month 3
Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment	Baseline, Week 12

Trial Locations

Locations (1)

The University Of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States