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

The University of Texas System (UT)

Status and phase: Terminated; Phase 2

Conditions: Hypertension; Proteinuria; Kidney Injury

Treatments: Drug: Placebo oral tablet; Drug: Isosorbide Mononitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04051957

HSC-MS-19-0429

Details and patient eligibility

About

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).

Enrollment: 9 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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9 participants in 2 patient groups, including a placebo group

Isosorbide Mononitrate

Experimental group

Treatment:

Drug: Isosorbide Mononitrate

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo oral tablet