Rituximab in Recurrent IgA Nephropathy

October 7, 2015 updated by: Wiwat Chancharoenthana, Chulalongkorn University

A Randomized, Prospective, Open-Label Study of Rituximab in the Treatment of Recurrent IgA Nephropathy With Active Endocapillary Proliferation Pathology

Currently, the treatment options of recurrent IgA nephropathy (IgAN) are conflicting and largely based on expert opinions. Consequently, the recent KDIGO clinical practice guideline for the care of kidney transplant recipients has concluded that there are no definite strategies for prevention and treatment. However, recurrent IgAN in the transplanted kidney is common and may contribute to graft loss, in particular, if cresentic formation, extra- or endocapillary proliferation were presented in kidney pathology. Herein, the investigators assume that rituximab, anti-CD20 Ab agent, can reduce circulating IgA with subsequently decrease rate of polymeric forms of IgA deposition in glomerular capillaries. Therefore, the investigators speculate that rituximab may have potential effect to reduce circulating polymeric forms of IgA and slow progression of recurrent IgAN.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hypothesis: In kidney transplant recipients with active endocapillary proliferation pathology of recurrent IgAN, an intravenous infusion of 375mg/m2 of rituximab on 4 consecutive monthly dose is superior to conventional therapy in reducing 24-hour proteinuria, and slowing progression of recurrent IgAN.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • Chulalongkorn University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any kidney transplant recipients between the age of 18 and 70 years of age and able to give informed consent
  • GFR by 24h Creatinine Clearance (CrCl) >30 ml/min/1.73m²
  • Biopsy proven recurrent IgA nephropathy with endocapillary proliferation pattern

Exclusion Criteria:

  • Clinical and histologic evidence of IgA combination with other forms of glomerulonephritis
  • Clinical evidence of cirrhosis, chronic active liver disease or known infection with hepatitis B, C or HIV
  • 24h CrCl <30 ml/min/1.73m² at the time of screening
  • Active systemic infection or history of serious infection within one month of entry
  • Positive pregnancy test or breast feeding at time of study entry
  • Patients receiving >6 months therapy with oral prednisone >5mg/day or glucocorticoid equivalent
  • Live vaccine within 28 days of study enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rituximab

Drug: Rituximab

•Rituximab 375 mg/m2 on treatment month 1, 2, 3, 4

Other Name: Mabthera
Drug: Intravenous Rituximab
- 375 mg/m2 rituximab be prescribed 4 consecutive monthly
Other Names:
  • Mabthera
Active Comparator: ACEI/ARB plus corticosteroids

Drug: ACEI/ARB

  • An ACEI and /or ARBs will be used to achieve proteinuria reduction and a blood pressure goal of <130/80 mmHg. Patients not attaining the target blood pressure with an ACEI or ARB alone should be treated with the combination of ACEI + ARB
  • Corticosteroids will be used as prednisolone 0.5 mg/kg/day with gradually taper off in 6-8 weeks to 5mg/day daily

Other Name: Enalapril, Lorsartan, Prednisolone
Drug: ACEI/ARB and corticosteroids
  • ACEI or ARB will be prescribed as high as tolerable dose.
  • Prednisolone will be prescribed starting as 0.5 mg/kg/day then taper off to 5 mg/day within 6-8 weeks
Other Names:
  • "Enalapril", "Lorsartan", "Prednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission rate
Time Frame: 12 months
Percentage of patients in each group achieving complete or partial response determined by proteinuria and 24-hour creatinine clearance
12 months
Incidence of all adverse events
Time Frame: 12 months
The incidence of adverse events such as serious infection, allergy, fever, headache, etc.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in allograft pathology following treatment
Time Frame: 12 months
The difference of active and chronic score report by BANFF score, HAAS, Oxford criteria between pre-treatment and post-treatment
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Wiwat Chancharoenthana, M.D., Ph.D., Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

October 7, 2015

First Posted (Estimate)

October 8, 2015

Study Record Updates

Last Update Posted (Estimate)

October 8, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WWC-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe