Pilot Study of Velcade® in IgA Nephropathy

Chronic Kidney Disease Clinical Trial

Official title:

Velcade Therapy for Severe IgA Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103778
• Other study ID #: X05320
• Secondary ID: 1001010854
• Status: Completed
• Phase: Phase 4
• Start date: July 2010
• Est. completion date: April 17, 2017

Study information

• Verified date: October 2018
• Source: The Rogosin Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 17, 2017
• Est. primary completion date: April 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	The Rogosin Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
The Rogosin Institute	Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hartono C, Chung M, Perlman AS, Chevalier JM, Serur D, Seshan SV, Muthukumar T. Bortezomib for Reduction of Proteinuria in IgA Nephropathy. Kidney Int Rep. 2018 Mar 11;3(4):861-866. doi: 10.1016/j.ekir.2018.03.001. eCollection 2018 Jul. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proteinuria	Quantification of urinary protein will be made after treatment by measuring 24 hr urine protein.	Baseline and 1 year
Primary	Number of Participants With Complete Remission, Partial Response, or no Response.	Complete remission was defined as daily proteinuria of less than 300mg measured by 24 hr urine collection.; Partial response was defined as any reduction in daily proteinuria from baseline as measure by 24 hr urine collection.	1 year
Secondary	Serum Creatinine	Preservation of renal function will be assessed.	Baseline and 1 year
Secondary	Number of Participants With Abnormal Lab Values or Infections Related to Exposure to Study Medication.	Complete blood count will be checked at regular intervals to monitor for anemia; liver panel; serum immunoglobulin profile will also be followed.	1 year

External Links

•   The Rogosin Institute