Pilot Study of Velcade® in IgA Nephropathy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2017-04-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Disease IgA Nephropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Velcade® therapy

Patients with greater than 1gm of proteinuria per day will receive Velcade®.

Group Type EXPERIMENTAL

Bortezomib (Velcade®)

Intervention Type DRUG

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

Interventions

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Bortezomib (Velcade®)

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

Intervention Type DRUG

Other Intervention Names

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Velcade® Bortezomib

Eligibility Criteria

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Inclusion Criteria

1. Male or female, 18 years of age or older.
2. Must have IgA nephropathy documented by kidney biopsy.
3. Must have greater than 1gm of proteinuria a day.
4. 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

1. Low platelet count and neutrophil count within certain limits defined for enrollment.
2. Underlying peripheral neuropathy.
3. 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.
4. Allergic to VELCADE®, boron or mannitol.
5. Female subjects who are pregnant or breast-feeding.
6. Recent use of investigational drug within 14 days before enrollment.
7. Having serious medical conditions and infections (including HIV,or hepatitis B or C) or psychiatric illness likely to interfere with participation in the study.
8. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No