NCT04051957

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 26, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2021

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 3, 2022

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

August 7, 2019

Results QC Date

June 30, 2022

Last Update Submit

August 2, 2022

Conditions

Kidney InjuryProteinuriaHypertension

Keywords

Kidney InjuryProteinuriaHypertensionAnti-VEGF

Outcome Measures

Primary Outcomes (3)

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

    Baseline, Month 1

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

    Baseline, Month 2

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

    Baseline, Month 3

Secondary Outcomes (15)

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

    Baseline, Month 1

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

    Baseline, Month 2

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

    Baseline, Month 3

  • 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

  • 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

  • +10 more secondary outcomes

Study Arms (2)

Isosorbide Mononitrate

EXPERIMENTAL
Drug: Isosorbide Mononitrate

Placebo

PLACEBO COMPARATOR
Drug: Placebo oral tablet

Interventions

Isosorbide MononitrateDRUG

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).

Isosorbide Mononitrate
Placebo oral tabletDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant women
  • Breast-feeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University Of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

ProteinuriaHypertension

Interventions

isosorbide-5-mononitrate

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Limitations and Caveats

Early termination due to the COVID pandemic and limited clinical face-to-face appointments leading to small numbers of subjects analyzed.

Results Point of Contact

Title
Jaya Kala, MD
Organization
The University of Texas Health Science Center at Houston
jaya.kala@uth.tmc.edu
713-500-6868

Study Officials

  • Jaya Kala, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 9, 2019

Study Start

September 26, 2019

Primary Completion

February 12, 2021

Study Completion

February 12, 2021

Last Updated

August 3, 2022

Results First Posted

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)