| Trial ID: | L0366 |
| Source ID: | NCT01103778
|
| Associated Drug: |
Bortezomib (Velcade®)
|
| Title: |
Pilot Study of Velcade® in IgA Nephropathy
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01103778/results
|
| Conditions: |
Chronic Kidney Disease|IgA Nephropathy
|
| Interventions: |
DRUG: Bortezomib (Velcade®)
|
| Outcome Measures: |
Primary: 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 | Secondary: 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., 1 year
|
| Sponsor/Collaborators: |
Sponsor: The Rogosin Institute | Collaborators: Weill Medical College of Cornell University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
11
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-07
|
| Completion Date: |
2017-04-17
|
| Results First Posted: |
2018-10-17
|
| Last Update Posted: |
2018-11-16
|
| Locations: |
The Rogosin Institute, New York, New York, 10021, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01103778
|
