CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 11 enrolled
Drug / intervention
Bortezomib (Velcade®)drug
Likely dose
Bortezomib (Velcade®) 1.3 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01103778
NCT01103778Phase 4Completed

Velcade Therapy for Severe IgA Nephropathy

The Rogosin Institute·interventional·Posted Apr 15, 2010·Updated Nov 16, 2018

In Brief

A Phase 4 clinical trial evaluating Bortezomib (Velcade®) for Chronic Kidney Disease and IgA Nephropathy. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 15, 2010
Enrollment StartJul 1, 2010
Primary CompletionApr 17, 2017
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 16.2 years ago

Interventions

Bortezomib (Velcade®)drug

Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).