Trial Outcomes & Findings for Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury (NCT NCT04051957)

NCT ID: NCT04051957

Last Updated: 2022-08-03

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 9 participants
• Primary outcome timeframe: Baseline, Month 1
• Results posted on: 2022-08-03

Participant Flow

Participant milestones

Measure	Isosorbide Mononitrate 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 Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
Overall Study STARTED	7	2
Overall Study COMPLETED	5	2
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Isosorbide Mononitrate n=7 Participants 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 n=2 Participants Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=7 Participants	0 Participants n=2 Participants	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=7 Participants	2 Participants n=2 Participants	9 Participants n=9 Participants
Age, Categorical >=65 years	0 Participants n=7 Participants	0 Participants n=2 Participants	0 Participants n=9 Participants
Sex: Female, Male Female	1 Participants n=7 Participants	0 Participants n=2 Participants	1 Participants n=9 Participants
Sex: Female, Male Male	6 Participants n=7 Participants	2 Participants n=2 Participants	8 Participants n=9 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	7 Participants n=7 Participants	2 Participants n=2 Participants	9 Participants n=9 Participants

PRIMARY outcome

Timeframe: Baseline, Month 1

Population: Data were not collected for 2 in the Isosorbide Mononitrate arm.

Outcome measures

Measure	Isosorbide Mononitrate n=5 Participants 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 n=2 Participants Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
Number of Participants With a Reduction in Urine Protein Creatinine Ratio (UPC) of > 500 mg/Day From That Measured Before Enrollment	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline, Month 2

Population: Data were not collected for 2 in the Isosorbide Mononitrate arm.

Outcome measures

Measure	Isosorbide Mononitrate n=5 Participants 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 n=2 Participants Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline, Month 3

Population: Data were not collected for 2 in the Isosorbide Mononitrate arm.

Outcome measures

Measure	Isosorbide Mononitrate n=5 Participants 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 n=2 Participants Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Month 1

Population: Data were not collected for 2 in the Isosorbide Mononitrate arm.

Outcome measures

Measure	Isosorbide Mononitrate n=5 Participants 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 n=2 Participants Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Month 2

Population: Data were not collected for 2 in the Isosorbide Mononitrate arm.

Outcome measures

Measure	Isosorbide Mononitrate n=5 Participants 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 n=2 Participants Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: Data were not collected for 2 in the Isosorbide Mononitrate arm.

Outcome measures

Measure	Isosorbide Mononitrate n=5 Participants 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 n=2 Participants Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 1

Population: Data were not collected for 3 in the Isosorbide Mononitrate arm.

Outcome measures

Measure	Isosorbide Mononitrate n=4 Participants 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 n=2 Participants Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
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	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2

Population: Data were not collected for 3 in the Isosorbide Mononitrate arm.

Outcome measures

Measure	Isosorbide Mononitrate n=4 Participants 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 n=2 Participants Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
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	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 3

Population: Data were not collected for 3 in the Isosorbide Mononitrate arm.

Outcome measures

Measure	Isosorbide Mononitrate n=4 Participants 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 n=2 Participants Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
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	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Data were not collected for 2 in the Isosorbide Mononitrate arm.

Outcome measures

Measure	Isosorbide Mononitrate n=5 Participants 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 n=2 Participants Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
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	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 5

Population: Data were not collected for 3 in the Isosorbide Mononitrate arm.

Outcome measures

Measure	Isosorbide Mononitrate n=4 Participants 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 n=2 Participants Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
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	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: Data were not collected for 3 in the Isosorbide Mononitrate arm.

Outcome measures

Measure	Isosorbide Mononitrate n=4 Participants 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 n=2 Participants Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
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	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 7

Population: Data were not collected for 3 in the Isosorbide Mononitrate arm.

Outcome measures

Measure	Isosorbide Mononitrate n=4 Participants 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 n=2 Participants Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
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	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Data were not collected for 2 in the Isosorbide Mononitrate arm.

Outcome measures

Measure	Isosorbide Mononitrate n=5 Participants 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 n=2 Participants Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
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	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 9

Population: Data were not collected for 3 in the Isosorbide Mononitrate arm.

Outcome measures

Measure	Isosorbide Mononitrate n=4 Participants 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 n=2 Participants Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
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	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 10

Population: Data were not collected for 3 in the Isosorbide Mononitrate arm.

Outcome measures

Measure	Isosorbide Mononitrate n=4 Participants 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 n=2 Participants Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
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	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 11

Population: Data were not collected for 3 in the Isosorbide Mononitrate arm.

Outcome measures

Measure	Isosorbide Mononitrate n=4 Participants 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 n=2 Participants Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
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	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Data were not collected for 2 in the Isosorbide Mononitrate arm.

Outcome measures

Measure	Isosorbide Mononitrate n=5 Participants 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 n=2 Participants Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
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	3 Participants	2 Participants

Adverse Events

Isosorbide Mononitrate

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Isosorbide Mononitrate n=7 participants at risk 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 n=2 participants at risk Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
General disorders Dizziness	14.3% 1/7 • Number of events 1 • 3 months	0.00% 0/2 • 3 months
Gastrointestinal disorders Nausea	14.3% 1/7 • Number of events 1 • 3 months	0.00% 0/2 • 3 months

Additional Information

Jaya Kala, MD

The University of Texas Health Science Center at Houston

Phone: 713-500-6868

Email: jaya.kala@uth.tmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place