Pilot Study of Velcade® in IgA Nephropathy
Completed · Phase 4
Conditions studied: Chronic Kidney Disease, IgA Nephropathy
In brief
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.
Key facts
- Study ID
- NCT01103778
- Run by
- The Rogosin Institute
- People needed
- 11
- Starts
- 2010-07-01
- Expected to finish
- 2017-04-17
- Last updated by the study team
- 2018-11-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The Rogosin Institute — New York, New York, United States
Full record on ClinicalTrials.gov
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