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TerminatedNCT04051957Updated Aug 3, 2022Results posted

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

A Phase 2 interventional study of Isosorbide Mononitrate and Placebo oral tablet in Kidney Injury, Proteinuria and Hypertension, sponsored by The University of Texas Health Science Center, Houston. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-08-03.

Sponsored by The University of Texas Health Science Center, Houston · Phase 2, Interventional, and Treatment

Why this study was terminated
Delays due to COVID and loss of research coordinator.
Phase
Phase 2
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Kidney Injury
  • Proteinuria
  • Hypertension

Keywords

  • Kidney Injury
  • Proteinuria
  • Hypertension
  • Anti-VEGF
03

In context

Proteinuria

234 studies on the registry are indexed under Proteinuria; 43 are open to participants now.

This study's enrollment of 9 is below the median of 60 across 164 interventional studies indexed under Proteinuria.

Browse Proteinuria studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Pregnant women
  • Breast-feeding women.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Isosorbide Mononitrate

    Drug: Isosorbide Mononitrate

  • Placebo comparator
    Placebo

    Drug: Placebo oral tablet

Interventions

  • DrugIsosorbide 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).

  • DrugPlacebo oral tablet

    Placebo will be given daily and will be doubled after 4 weeks of start of therapy.

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline, Month 1

  2. Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment

    Time frame: Baseline, Month 2

  3. Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment

    Time frame: Baseline, Month 3

Secondary outcomes

  1. Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment

    Time frame: Baseline, Month 1

  2. Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment

    Time frame: Baseline, Month 2

  3. Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment

    Time frame: Baseline, Month 3

  4. 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

    Time frame: Baseline, Week 1

  5. 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

    Time frame: Baseline, Week 2

  6. 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

    Time frame: Baseline, Week 3

  7. 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

    Time frame: Baseline, Week 4

  8. 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

    Time frame: Baseline, Week 5

  9. 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

    Time frame: Baseline, Week 6

  10. 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

    Time frame: Baseline, Week 7

  11. 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

    Time frame: Baseline, Week 8

  12. 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

    Time frame: Baseline, Week 9

  13. 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

    Time frame: Baseline, Week 10

  14. 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

    Time frame: Baseline, Week 11

  15. 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

    Time frame: Baseline, Week 12

07

Results

Posted Aug 3, 2022
Limitations and caveats
Early termination due to the COVID pandemic and limited clinical face-to-face appointments leading to small numbers of subjects analyzed.

Participant flow

Participant flow — Overall Study
MilestoneIsosorbide MononitratePlacebo
Started72
Completed52
Not completed20

Outcome measures

PrimaryNumber of Participants With a Reduction in Urine Protein Creatinine Ratio (UPC) of > 500 mg/Day From That Measured Before Enrollment
Time frame:
Baseline, Month 1
Reported as:
Count of participants · Participants
Number of Participants With a Reduction in Urine Protein Creatinine Ratio (UPC) of > 500 mg/Day From That Measured Before Enrollment
ParticipantsIsosorbide MononitratePlacebo
Number of Participants With a Reduction in Urine Protein Creatinine Ratio (UPC) of > 500 mg/Day From That Measured Before Enrollment10
PrimaryNumber of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment
Time frame:
Baseline, Month 2
Reported as:
Count of participants · Participants
Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment
ParticipantsIsosorbide MononitratePlacebo
Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment10
PrimaryNumber of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment
Time frame:
Baseline, Month 3
Reported as:
Count of participants · Participants
Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment
ParticipantsIsosorbide MononitratePlacebo
Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment31
SecondaryNumber of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment
Time frame:
Baseline, Month 1
Reported as:
Count of participants · Participants
Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment
ParticipantsIsosorbide MononitratePlacebo
Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment00
SecondaryNumber of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment
Time frame:
Baseline, Month 2
Reported as:
Count of participants · Participants
Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment
ParticipantsIsosorbide MononitratePlacebo
Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment00
SecondaryNumber of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment
Time frame:
Baseline, Month 3
Reported as:
Count of participants · Participants
Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment
ParticipantsIsosorbide MononitratePlacebo
Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment10
SecondaryNumber 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
Time frame:
Baseline, Week 1
Reported as:
Count of participants · Participants
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
ParticipantsIsosorbide MononitratePlacebo
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 Enrollment01
SecondaryNumber 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
Time frame:
Baseline, Week 2
Reported as:
Count of participants · Participants
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
ParticipantsIsosorbide MononitratePlacebo
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 Enrollment21
SecondaryNumber 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
Time frame:
Baseline, Week 3
Reported as:
Count of participants · Participants
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
ParticipantsIsosorbide MononitratePlacebo
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 Enrollment31
SecondaryNumber 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
Time frame:
Baseline, Week 4
Reported as:
Count of participants · Participants
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
ParticipantsIsosorbide MononitratePlacebo
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 Enrollment42
SecondaryNumber 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
Time frame:
Baseline, Week 5
Reported as:
Count of participants · Participants
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
ParticipantsIsosorbide MononitratePlacebo
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 Enrollment21
SecondaryNumber 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
Time frame:
Baseline, Week 6
Reported as:
Count of participants · Participants
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
ParticipantsIsosorbide MononitratePlacebo
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 Enrollment32
SecondaryNumber 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
Time frame:
Baseline, Week 7
Reported as:
Count of participants · Participants
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
ParticipantsIsosorbide MononitratePlacebo
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 Enrollment32
SecondaryNumber 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
Time frame:
Baseline, Week 8
Reported as:
Count of participants · Participants
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
ParticipantsIsosorbide MononitratePlacebo
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 Enrollment32
SecondaryNumber 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
Time frame:
Baseline, Week 9
Reported as:
Count of participants · Participants
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
ParticipantsIsosorbide MononitratePlacebo
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 Enrollment32
SecondaryNumber 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
Time frame:
Baseline, Week 10
Reported as:
Count of participants · Participants
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
ParticipantsIsosorbide MononitratePlacebo
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 Enrollment22
SecondaryNumber 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
Time frame:
Baseline, Week 11
Reported as:
Count of participants · Participants
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
ParticipantsIsosorbide MononitratePlacebo
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 Enrollment32
SecondaryNumber 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
Time frame:
Baseline, Week 12
Reported as:
Count of participants · Participants
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
ParticipantsIsosorbide MononitratePlacebo
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 Enrollment32

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Isosorbide Mononitrate0/7 (0%)0/7 (0%)2/7 (28.6%)
Placebo0/2 (0%)0/2 (0%)0/2 (0%)
Most frequent other events
Most frequent other events
EventIsosorbide MononitratePlacebo
DizzinessGeneral disorders1/70/2
NauseaGastrointestinal disorders1/70/2

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Isosorbide MononitratePlaceboTotal
<=18 years000
Between 18 and 65 years729
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Isosorbide MononitratePlaceboTotal
Female101
Male628
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Isosorbide MononitratePlaceboTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(Participants)Isosorbide MononitratePlaceboTotal
United States729
08

Study locations

1 site
  • The University Of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
09

References and documents

Study documents

  • Study protocol · Oct 24, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04051957
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Kidney Foundation
Responsible party
Jaya Kala (Assistant Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Aug 9, 2019
Start date
Sep 26, 2019
Primary completion
Feb 12, 2021
Completion
Feb 12, 2021
Results posted
Aug 3, 2022
Last update
Aug 3, 2022

Study contacts

Jaya Kala, MD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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