Phase 4
Completed N=11
Pilot Study of Velcade® in IgA Nephropathy
Source: ClinicalTrials.gov NCT01103778 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Proteinuria — 2.52; 1.43 grams per 24 hrs
◆ Published Evidence
Established
64citations · ~8 / year
Bortezomib for Reduction of Proteinuria in IgA Nephropathy.
Summary
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.
Linked Publications (3)
-
Bortezomib for Reduction of Proteinuria in IgA Nephropathy.
-
Emerging therapies in immunoglobulin A nephropathy.
-
Treating IgA nephropathy: quid novi?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proteinuria |
2.52; 1.43 | — |
| PRIMARY Number of Participants With Complete Remission, Partial Response, or no Response. |
3; 1; 3 | — |
| SECONDARY Serum Creatinine |
1.35; 1.52 | — |
| SECONDARY Number of Participants With Abnormal Lab Values or Infections Related to Exposure to Study Medication. |
1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01103778) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.