Pilot Study of Velcade® in IgA Nephropathy

NCT01103778 | Completed Phase 4 Results

• 2 other identifiers: X053201001010854
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease; IgA Nephropathy

Keywords

Chronic kidney disease; IgA nephropathy; Velcade®; Proteinuria; Bortezomib; Proteasome inhibitor

Outcome Measures

Primary Outcomes (2)

• Proteinuria

  Quantification of urinary protein will be made after treatment by measuring 24 hr urine protein.

  Baseline and 1 year

• 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 Outcomes (2)

• Serum Creatinine

  Baseline and 1 year

• Number of Participants With Abnormal Lab Values or Infections Related to Exposure to Study Medication.

  1 year

Study Arms (1)

Velcade® therapy

EXPERIMENTAL

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

Drug: Bortezomib (Velcade®)

Interventions

Bortezomib (Velcade®) DRUG

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

Also known as: Velcade®, Bortezomib

Velcade® therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Rogosin Institute: lead
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

The Rogosin Institute

New York, New York, 10021, United States

Location

Related Publications (3)

• 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.

  PMID: 29988921 RESULT

• Yeo SC, Liew A, Barratt J. Emerging therapies in immunoglobulin A nephropathy. Nephrology (Carlton). 2015 Nov;20(11):788-800. doi: 10.1111/nep.12527.

  PMID: 26032537 DERIVED

• Hartono C, Muthukumar T. Treating IgA nephropathy: quid novi? Discov Med. 2014 Mar;17(93):131-8.

  PMID: 24641955 DERIVED

Related Links

• The Rogosin Institute

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Glomerulonephritis, IGA; Proteinuria

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glomerulonephritis; Nephritis; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Our pilot study has several significant limitations, including small sample size, no control group, and nonrandomization.

Results Point of Contact

• Title: Dr. Choli Hartono
• Organization: Rogosin Institute

chh2001@nyp.org

212-746-1578

Study Officials

• Choli Hartono, MD

  The Rogosin Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 15, 2010
• Study Start: July 1, 2010
• Primary Completion: April 17, 2017
• Study Completion: April 17, 2017
• Last Updated: November 16, 2018
• Results First Posted: October 17, 2018

Record last verified: 2018-10

Locations

US (1)