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Delays due to COVID and loss of research coordinator.
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| Name | Class |
|---|---|
| National Kidney Foundation, United States | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isosorbide Mononitrate | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isosorbide Mononitrate | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaya Kala, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University Of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | Placebo | Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Reduction in Urine Protein Creatinine Ratio (UPC) of > 500 mg/Day From That Measured Before Enrollment | Data were not collected for 2 in the Isosorbide Mononitrate arm. | Posted | Count of Participants | Participants | Baseline, Month 1 |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | Systematic Assessment |
Early termination due to the COVID pandemic and limited clinical face-to-face appointments leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaya Kala, MD | The University of Texas Health Science Center at Houston | 713-500-6868 | jaya.kala@uth.tmc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 24, 2019 | Jul 28, 2022 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D011507 | Proteinuria |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C030397 | isosorbide-5-mononitrate |
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Double blinded
| Placebo oral tablet | Drug | 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 | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment | Data were not collected for 2 in the Isosorbide Mononitrate arm. | Posted | Count of Participants | Participants | Baseline, Month 2 |
|
|
|
| Primary | Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment | Data were not collected for 2 in the Isosorbide Mononitrate arm. | Posted | Count of Participants | Participants | Baseline, Month 3 |
|
|
|
| Secondary | Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment | Data were not collected for 2 in the Isosorbide Mononitrate arm. | Posted | Count of Participants | Participants | Baseline, Month 1 |
|
|
|
| Secondary | Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment | Data were not collected for 2 in the Isosorbide Mononitrate arm. | Posted | Count of Participants | Participants | Baseline, Month 2 |
|
|
|
| Secondary | Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment | Data were not collected for 2 in the Isosorbide Mononitrate arm. | Posted | Count of Participants | Participants | 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 | Data were not collected for 3 in the Isosorbide Mononitrate arm. | Posted | Count of Participants | Participants | 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 | Data were not collected for 3 in the Isosorbide Mononitrate arm. | Posted | Count of Participants | Participants | 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 | Data were not collected for 3 in the Isosorbide Mononitrate arm. | Posted | Count of Participants | Participants | 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 | Data were not collected for 2 in the Isosorbide Mononitrate arm. | Posted | Count of Participants | Participants | 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 | Data were not collected for 3 in the Isosorbide Mononitrate arm. | Posted | Count of Participants | Participants | 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 | Data were not collected for 3 in the Isosorbide Mononitrate arm. | Posted | Count of Participants | Participants | 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 | Data were not collected for 3 in the Isosorbide Mononitrate arm. | Posted | Count of Participants | Participants | 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 | Data were not collected for 2 in the Isosorbide Mononitrate arm. | Posted | Count of Participants | Participants | 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 | Data were not collected for 3 in the Isosorbide Mononitrate arm. | Posted | Count of Participants | Participants | 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 | Data were not collected for 3 in the Isosorbide Mononitrate arm. | Posted | Count of Participants | Participants | 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 | Data were not collected for 3 in the Isosorbide Mononitrate arm. | Posted | Count of Participants | Participants | 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 | Data were not collected for 2 in the Isosorbide Mononitrate arm. | Posted | Count of Participants | Participants | Baseline, Week 12 |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 2 |
| 7 |
| EG001 | Placebo | Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy. | 0 | 2 | 0 | 2 | 0 | 2 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |