NCT04051957

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

Terminated Phase 2 Results posted Last updated 3 August 2022

What this trial tests

Phase 2 trial testing Isosorbide Mononitrate in Kidney Injury in 9 participants. Terminated before completion.

Timeline

26 September 2019

Primary endpoint
12 February 2021

12 February 2021

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	9
Start date	26 September 2019
Primary completion	12 February 2021
Estimated completion	12 February 2021
Sites	1 location across United States

Drugs / interventions tested

• Isosorbide Mononitrate (ISOSORBIDE MONONITRATE) — full drug profile →
• Placebo oral tablet — full drug profile →

Conditions studied

• Kidney Injury — all drugs for Kidney Injury →
• Proteinuria — all drugs for Proteinuria →
• Hypertension — all drugs for Hypertension →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

Adults 18 to 65, any sex, with Kidney Injury or Proteinuria. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With a Reduction in Urine Protein Creatinine Ratio (UPC) of > 500 mg/Day From That Measured Before Enrollment Primary · Baseline, Month 1

Group	Value	95% CI
Isosorbide Mononitrate	1
Placebo	0

Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment Primary · Baseline, Month 2

Group	Value	95% CI
Isosorbide Mononitrate	1
Placebo	0

Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment Primary · Baseline, Month 3

Group	Value	95% CI
Isosorbide Mononitrate	3
Placebo	1

Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment Secondary · Baseline, Month 1

Group	Value	95% CI
Isosorbide Mononitrate	0
Placebo	0

Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment Secondary · Baseline, Month 2

Group	Value	95% CI
Isosorbide Mononitrate	0
Placebo	0

Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment Secondary · Baseline, Month 3

Group	Value	95% CI
Isosorbide Mononitrate	1
Placebo	0

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 Secondary · Baseline, Week 1

Group	Value	95% CI
Isosorbide Mononitrate	0
Placebo	1

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 Secondary · Baseline, Week 2

Group	Value	95% CI
Isosorbide Mononitrate	2
Placebo	1

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 Secondary · Baseline, Week 3

Group	Value	95% CI
Isosorbide Mononitrate	3
Placebo	1

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 Secondary · Baseline, Week 4

Group	Value	95% CI
Isosorbide Mononitrate	4
Placebo	2

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 Secondary · Baseline, Week 5

Group	Value	95% CI
Isosorbide Mononitrate	2
Placebo	1

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 Secondary · Baseline, Week 6

Group	Value	95% CI
Isosorbide Mononitrate	3
Placebo	2

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Isosorbide Mononitrate

Serious: 0/7 (0%)

Deaths: 0/7

Placebo

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (2 terms — click to expand)

Reaction	System	Isosorbide Mononitrate	Placebo
Dizziness	General disorders	—	—
Nausea	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT04051957 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.