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| ID | Type | Description | Link |
|---|---|---|---|
| 1001010854 | Other Identifier | Weill Cornell Medical College IRB |
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| Name | Class |
|---|---|
| Weill Medical College of Cornell University | OTHER |
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The primary objective of this study is to investigate the ability of Velcade® (bortezomib) to induce complete or partial remission in patients with severe IgA nephropathy.
The secondary objectives are to assess clinical outcomes relating to safety and efficacy, such as infection, malignancy, preservation of renal function, partial responders, relapse rate, and to study mechanistic assays to predict remission.
This exploratory single center, open-label, single treatment group assignment, safety and efficacy study will enroll 15 patients with severe IgA nephropathy. Subjects will receive 1 cycle of Velcade® to induce clinical remission. Follow-up visits will occur monthly for a year.
For this pilot study, the proportion of patients with clinical remission or partial response will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Velcade® therapy | Experimental | Patients with greater than 1gm of proteinuria per day will receive Velcade®. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib (Velcade®) | Drug | Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proteinuria | Quantification of urinary protein will be made after treatment by measuring 24 hr urine protein. | Baseline and 1 year |
| Number of Participants With Complete Remission, Partial Response, or no Response. | Complete remission was defined as daily proteinuria of less than 300mg measured by 24 hr urine collection. Partial response was defined as any reduction in daily proteinuria from baseline as measure by 24 hr urine collection. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Creatinine | Preservation of renal function will be assessed. | Baseline and 1 year |
| Number of Participants With Abnormal Lab Values or Infections Related to Exposure to Study Medication. | Complete blood count will be checked at regular intervals to monitor for anemia; liver panel; serum immunoglobulin profile will also be followed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Choli Hartono, MD | The Rogosin Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Rogosin Institute | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29988921 | Result | Hartono C, Chung M, Perlman AS, Chevalier JM, Serur D, Seshan SV, Muthukumar T. Bortezomib for Reduction of Proteinuria in IgA Nephropathy. Kidney Int Rep. 2018 Mar 11;3(4):861-866. doi: 10.1016/j.ekir.2018.03.001. eCollection 2018 Jul. | |
| 26032537 | Derived | Yeo SC, Liew A, Barratt J. Emerging therapies in immunoglobulin A nephropathy. Nephrology (Carlton). 2015 Nov;20(11):788-800. doi: 10.1111/nep.12527. |
| Label | URL |
|---|---|
| The Rogosin Institute | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Velcade Arm | Single treatment arm: Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients with greater than 1gm of proteinuria per day will receive Velcade®.
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| ID | Title | Description |
|---|---|---|
| BG000 | Velcade® Therapy | Bortezomib (Velcade®): Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle). |
| 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 | Proteinuria | Quantification of urinary protein will be made after treatment by measuring 24 hr urine protein. | 1 participant was lost to followup. | Posted | Median | Full Range | grams per 24 hrs | Baseline and 1 year |
|
|
1 year
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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 | Velcade® Therapy | Patients with greater than 1gm of proteinuria per day will receive Velcade®. Bortezomib (Velcade®): Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild reversible decline platelet count | Blood and lymphatic system disorders | Systematic Assessment | Related to exposure to study medication |
Our pilot study has several significant limitations, including small sample size, no control group, and nonrandomization.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Choli Hartono | Rogosin Institute | 212-746-1578 | chh2001@nyp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 28, 2011 | Sep 21, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D005922 | Glomerulonephritis, IGA |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| 1 year |
| 24641955 | Derived | Hartono C, Muthukumar T. Treating IgA nephropathy: quid novi? Discov Med. 2014 Mar;17(93):131-8. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| Primary | Number of Participants With Complete Remission, Partial Response, or no Response. | Complete remission was defined as daily proteinuria of less than 300mg measured by 24 hr urine collection. Partial response was defined as any reduction in daily proteinuria from baseline as measure by 24 hr urine collection. | 1 participant was lost to followup. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Serum Creatinine | Preservation of renal function will be assessed. | 1 participant lost to followup. | Posted | Median | Full Range | milligram per deciliter | Baseline and 1 year |
|
|
|
| Secondary | Number of Participants With Abnormal Lab Values or Infections Related to Exposure to Study Medication. | Complete blood count will be checked at regular intervals to monitor for anemia; liver panel; serum immunoglobulin profile will also be followed. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|