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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-26

Study Completion Date

2021-02-12

Brief Summary

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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).

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Detailed Description

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Conditions

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Kidney Injury Proteinuria Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Double blinded

Study Groups

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Isosorbide Mononitrate

Group Type EXPERIMENTAL

Isosorbide Mononitrate

Intervention Type DRUG

The starting dose will be Isosorbide Mononitrate 60 mg ER daily and after 4 weeks, if tolerated but response is not achieved, the dose will be escalated to Isosorbide Mononitrate 120 mg ER daily (2 tabs of 60 mg ER tablets).

Placebo

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Placebo will be given daily and will be doubled after 4 weeks of start of therapy.

Interventions

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Isosorbide Mononitrate

The starting dose will be Isosorbide Mononitrate 60 mg ER daily and after 4 weeks, if tolerated but response is not achieved, the dose will be escalated to Isosorbide Mononitrate 120 mg ER daily (2 tabs of 60 mg ER tablets).

Intervention Type DRUG

Placebo oral tablet

Placebo will be given daily and will be doubled after 4 weeks of start of therapy.

Intervention Type DRUG

Eligibility Criteria

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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.