Pilot Study of Velcade® in IgA Nephropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01103778
• Date of registration: 13/04/2010
• Prospective Registration: Yes
• Primary sponsor: The Rogosin Institute
• Public title: Pilot Study of Velcade® in IgA Nephropathy
• Scientific title: Velcade Therapy for Severe IgA Nephropathy
• Date of first enrolment: July 2010
• Target sample size: 11
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01103778
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Choli Hartono, MD
• Affiliation: The Rogosin Institute

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

IgA Nephropathy

Chronic Kidney Disease

Intervention(s)

Drug: Bortezomib (Velcade®)

Primary Outcome(s)

Number of Participants With Complete Remission, Partial Response, or no Response. [Time Frame: 1 year]

Proteinuria [Time Frame: Baseline and 1 year]

Secondary Outcome(s)

Number of Participants With Abnormal Lab Values or Infections Related to Exposure to Study Medication. [Time Frame: 1 year]

Serum Creatinine [Time Frame: Baseline and 1 year]

Secondary ID(s)

X05320

1001010854

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Weill Medical College of Cornell University

Results

• Results available: Yes
• Date Posted: 17/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01103778