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Rituximab in Recurrent IgA Nephropathy

Primary Purpose

Recurrent IgA Nephropathy

Status

Unknown status

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Intravenous Rituximab

ACEI/ARB and corticosteroids

About this trial

This is an interventional treatment trial for Recurrent IgA Nephropathy focused on measuring Recurrent IgA nephropathy, Rituximab

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chulalongkorn UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rituximab

ACEI/ARB plus corticosteroids

Arm Description

Drug: Rituximab •Rituximab 375 mg/m2 on treatment month 1, 2, 3, 4 Other Name: Mabthera

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

Outcomes

Primary Outcome Measures

Remission rate

Percentage of patients in each group achieving complete or partial response determined by proteinuria and 24-hour creatinine clearance

Incidence of all adverse events

The incidence of adverse events such as serious infection, allergy, fever, headache, etc.

Secondary Outcome Measures

Change in allograft pathology following treatment

The difference of active and chronic score report by BANFF score, HAAS, Oxford criteria between pre-treatment and post-treatment

Full Information

NCT ID

NCT02571842

First Posted

October 6, 2015

Last Updated

October 7, 2015

Sponsor

Chulalongkorn University

1. Study Identification

Unique Protocol Identification Number

NCT02571842

Brief Title

Rituximab in Recurrent IgA Nephropathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chulalongkorn University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent IgA Nephropathy

Keywords

Recurrent IgA nephropathy, Rituximab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rituximab

Arm Type

Experimental

Arm Description

Drug: Rituximab •Rituximab 375 mg/m2 on treatment month 1, 2, 3, 4 Other Name: Mabthera

Arm Title

ACEI/ARB plus corticosteroids

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Intravenous Rituximab

Other Intervention Name(s)

Mabthera

Intervention Description

- 375 mg/m2 rituximab be prescribed 4 consecutive monthly

Intervention Type

Drug

Intervention Name(s)

ACEI/ARB and corticosteroids

Other Intervention Name(s)

"Enalapril", "Lorsartan", "Prednisolone

Intervention Description

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

Primary Outcome Measure Information:

Title

Remission rate

Description

Percentage of patients in each group achieving complete or partial response determined by proteinuria and 24-hour creatinine clearance

Time Frame

12 months

Title

Incidence of all adverse events

Description

The incidence of adverse events such as serious infection, allergy, fever, headache, etc.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Change in allograft pathology following treatment

Description

The difference of active and chronic score report by BANFF score, HAAS, Oxford criteria between pre-treatment and post-treatment

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wiwat Chancharoenthana, M.D., Ph.D.

wiwatmd@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wiwat Chancharoenthana, M.D., Ph.D.

Organizational Affiliation

Chulalongkorn University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chulalongkorn University

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wiwat Chancharoenthana, M.D., Ph.D.

Phone

6622564251

Ext

106

wiwatmd@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Rituximab in Recurrent IgA Nephropathy

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