Rituximab in Recurrent IgA Nephropathy

Sponsor
Chulalongkorn University
Study ID
NCT02571842
Phase
PHASE4
Status
Unknown

Conditions

  • Recurrent IgA Nephropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Intravenous Rituximab — DRUG
    \- 375 mg/m2 rituximab be prescribed 4 consecutive monthly
  • ACEI/ARB and corticosteroids — DRUG
    * 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

Study Details

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.

Key Dates

Start date
Jan 31, 2012
Status verified
Oct 2015
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Remission rate [ Time Frame: 12 months ]

Central Contacts