Pilot Study of Velcade® in IgA Nephropathy
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01103778 |
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Recruitment Status :
Completed
First Posted : April 15, 2010
Results First Posted : October 17, 2018
Last Update Posted : November 16, 2018
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Kidney Disease IgA Nephropathy | Drug: Bortezomib (Velcade®) | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 11 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Velcade Therapy for Severe IgA Nephropathy |
| Study Start Date : | July 2010 |
| Actual Primary Completion Date : | April 17, 2017 |
| Actual Study Completion Date : | April 17, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Velcade® therapy
Patients with greater than 1gm of proteinuria per day will receive Velcade®.
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Drug: Bortezomib (Velcade®)
Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).
Other Names:
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- Proteinuria [ Time Frame: Baseline and 1 year ]Quantification of urinary protein will be made after treatment by measuring 24 hr urine protein.
- Number of Participants With Complete Remission, Partial Response, or no Response. [ Time Frame: 1 year ]
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.
- Serum Creatinine [ Time Frame: Baseline and 1 year ]Preservation of renal function will be assessed.
- Number of Participants With Abnormal Lab Values or Infections Related to Exposure to Study Medication. [ Time Frame: 1 year ]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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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female, 18 years of age or older.
- Must have IgA nephropathy documented by kidney biopsy.
- Must have greater than 1gm of proteinuria a day.
- Must be on a stable dose of Angiotensin Converting Enzyme Inhibitor (ACEI) and/or Angiotensin Receptor Blocking agent (ARB) for at least 4 weeks prior to screening.
Exclusion Criteria:
- Low platelet count and neutrophil count within certain limits defined for enrollment.
- Underlying peripheral neuropathy.
- Having cardiac problems, such as myocardial infarction, heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Allergic to VELCADE®, boron or mannitol.
- Female subjects who are pregnant or breast-feeding.
- Recent use of investigational drug within 14 days before enrollment.
- Having serious medical conditions and infections (including HIV,or hepatitis B or C) or psychiatric illness likely to interfere with participation in the study.
- Diagnosed or treated for cancer within 3 years of participation in the study, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low-risk prostate cancer after curative therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103778
| United States, New York | |
| The Rogosin Institute | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | Choli Hartono, MD | The Rogosin Institute |
Documents provided by The Rogosin Institute:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | The Rogosin Institute |
| ClinicalTrials.gov Identifier: | NCT01103778 |
| Other Study ID Numbers: |
X05320 1001010854 ( Other Identifier: Weill Cornell Medical College IRB ) |
| First Posted: | April 15, 2010 Key Record Dates |
| Results First Posted: | October 17, 2018 |
| Last Update Posted: | November 16, 2018 |
| Last Verified: | October 2018 |
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Chronic kidney disease IgA nephropathy Velcade® |
Proteinuria Bortezomib Proteasome inhibitor |
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Kidney Diseases Renal Insufficiency, Chronic Glomerulonephritis, IGA Urologic Diseases Renal Insufficiency Glomerulonephritis |
Nephritis Autoimmune Diseases Immune System Diseases Bortezomib Antineoplastic Agents |