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

The University of Texas System (UT) logo

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

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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