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Rituximab in Recurrent IgA Nephropathy

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ClinicalTrials.gov Identifier: NCT02571842
Recruitment Status : Unknown
Verified October 2015 by Wiwat Chancharoenthana, Chulalongkorn University.
Recruitment status was:  Recruiting
First Posted : October 8, 2015
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
Wiwat Chancharoenthana, Chulalongkorn University

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.

Condition or disease Intervention/treatment Phase
Recurrent IgA Nephropathy Drug: Intravenous Rituximab Drug: ACEI/ARB and corticosteroids Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, Open-Label Study of Rituximab in the Treatment of Recurrent IgA Nephropathy With Active Endocapillary Proliferation Pathology
Study Start Date : January 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Rituximab

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 Name: 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 Name: "Enalapril", "Lorsartan", "Prednisolone




Primary Outcome Measures :
  1. 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

  2. Incidence of all adverse events [ Time Frame: 12 months ]
    The incidence of adverse events such as serious infection, allergy, fever, headache, etc.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02571842


Contacts
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Contact: Wiwat Chancharoenthana, M.D., Ph.D. wiwatmd@hotmail.com

Locations
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Thailand
Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Wiwat Chancharoenthana, M.D., Ph.D.    6622564251 ext 106    wiwatmd@hotmail.com   
Sponsors and Collaborators
Chulalongkorn University
Investigators
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Principal Investigator: Wiwat Chancharoenthana, M.D., Ph.D. Chulalongkorn University

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Responsible Party: Wiwat Chancharoenthana, Dr., Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02571842     History of Changes
Other Study ID Numbers: WWC-006
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2015
Keywords provided by Wiwat Chancharoenthana, Chulalongkorn University:
Recurrent IgA nephropathy
Rituximab
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Rituximab
Enalapril
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents