Pilot Study of Velcade® in IgA Nephropathy

The Rogosin Institute

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease; IgA Nephropathy

Treatments: Drug: Bortezomib (Velcade®)

Study type: Interventional

Funder types: Other

Identifiers

NCT01103778

X05320

1001010854 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

11 participants in 1 patient group

Velcade® therapy

Experimental group

Description:

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

Treatment:

Drug: Bortezomib (Velcade®)