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. 2020 Mar 12;2020(3):CD003965. doi: 10.1002/14651858.CD003965.pub3

NCT02571842.

Methods Parallel RCT
Participants
  • Setting: single centre

  • Country: Thailand

  • Any kidney transplant recipients between the age of 18 and 70 years of age and able to give informed consent; GFR by 24‐hour CrCl > 30 mL/min/1.73 m2; biopsy‐proven recurrent IgAN with endocapillary proliferation pattern

  • Number: 30 participants planned

  • Mean age ± SD (years): not available

  • Sex (M/F): not available

  • Exclusion criteria: clinical and histologic evidence of IgA combination with other forms of GN; clinical evidence of cirrhosis, chronic active liver disease or known infection with hepatitis B, C or HIV; 24‐hour CrCl < 30 mL/min/1.73 m2 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 > 5 mg/day or glucocorticoid equivalent; live vaccine within 28 days of study enrolment

Interventions Treatment group 1
  • Rituximab: 375 mg/m2 on treatment month 1, 2, 3, 4


Treatment group 2
  • An ACEI and/or ARB will be used to achieve proteinuria reduction and a BP goal of < 130/80 mmHg. Patients not attaining the target BP 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 to 8 weeks to 5 mg/day daily

Outcomes
  • Remission rate

  • Incidence of all adverse events

Notes Study completed on December 2016
Email investigators to request update on trial status, but not answer was provided
Clinicaltrials.gov identifier: NCT02571842
No study results available

ACEi ‐ angiotensin‐converting enzyme inhibitor; ARB ‐ angiotensin receptor blocker; BP ‐ blood pressure; CPA ‐ cyclophosphamide; CrCl ‐ creatinine clearance; CSA ‐ cyclosporin A; (e)GFR ‐ (estimated) glomerular filtration rate; GN ‐ glomerulonephritis; HIV ‐ human immunodeficiency virus; HSP ‐ Henoch‐Schönlein Purpura; IgAN ‐ IgA nephropathy; IV ‐ intravenous; MMF ‐ mycophenolate mofetil; RCT ‐ randomised controlled study; SLE ‐ systemic lupus erythematosus; UACR ‐ urine albumin creatinine ratio