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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04051957
• Other study ID #: HSC-MS-19-0429
• Status: Terminated
• Phase: Phase 2
• Start date: September 26, 2019
• Est. completion date: February 12, 2021

Study information

• Verified date: August 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: February 12, 2021
• Est. primary completion date: February 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Kidney Injury
• Proteinuria
• Wounds and Injuries

Intervention

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).
• Placebo oral tablet
Placebo will be given daily and will be doubled after 4 weeks of start of therapy.

Locations

Country	Name	City	State
United States	The University Of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Kidney Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a Reduction in Urine Protein Creatinine Ratio (UPC) of > 500 mg/Day From That Measured Before Enrollment		Baseline, Month 1
Primary	Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment		Baseline, Month 2
Primary	Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment		Baseline, Month 3
Secondary	Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) =25% From Before Enrollment		Baseline, Month 1
Secondary	Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) =25% From Before Enrollment		Baseline, Month 2
Secondary	Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) =25% From Before Enrollment		Baseline, Month 3
Secondary	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 1
Secondary	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 2
Secondary	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 3
Secondary	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 4
Secondary	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 5
Secondary	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 6
Secondary	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 7
Secondary	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 8
Secondary	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 9
Secondary	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 10
Secondary	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 11
Secondary	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