NCT04051957

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Kidney Injury
• Proteinuria
• Hypertension

Interventions

Type	Name	Description
DRUG	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).
DRUG	Placebo oral tablet	Placebo will be given daily and will be doubled after 4 weeks of start of therapy.

Timeline

• Start date: 2019-09-26
• Primary completion: 2021-02-12
• Completion: 2021-02-12
• First posted: 2019-08-09
• Last updated: 2022-08-03
• Results posted: 2022-08-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study