Microscopic Polyangiitis Clinical Trial
Official title:
Randomised Trial of Plasma Exchange or High Dose Methyl Prednisolone as Adjunctive Therapy for Severe Renal Vasculitis
The purpose of this study is to test whether additional therapy with plasma exchange improves the chances of kidney recovery in severe kidney vasculitis.
Primary systemic vasculitis associated with autoantibodies to neutrophil cytoplasmic
antigens (ANCA), is the most frequent cause of rapidly progressive glomerulonephritis. Renal
failure at presentation often progresses to end stage renal disease despite
immunosuppressive therapy. We investigated whether the addition of plasma exchange was more
effective than intravenous (IV) methyl prednisolone in the achievement of renal recovery for
ANCA associated systemic vasculitis presenting with a serum creatinine above 500umol/l
(5.8mg/dl).
137 patients with a new diagnosis of ANCA associated systemic vasculitis, serum creatinine
above 500umol/l (5.8mg/dl) and a renal biopsy demonstrating a focal, necrotizing
glomerulonephritis were randomized to receive seven plasma exchanges or IV methyl
prednisolone 1000mg/day for three days. Both groups were treated with cyclophosphamide and
oral prednisolone. The primary end-point was dialysis independence with a serum creatinine
below 500umol/l (5.8mg/dl) at three months. Secondary end-points included renal and patient
survival at 12 months and severe adverse event rates.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT01729624 -
PRO Development for ANCA Associated Vasculitis
|
N/A | |
Terminated |
NCT02474888 -
Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis
|
||
Active, not recruiting |
NCT02198248 -
Low-dose Glucocorticoid Vasculitis Induction Study
|
Phase 4 | |
Completed |
NCT02190916 -
Vasculitis Illness Perception (VIP) Study
|
N/A | |
Recruiting |
NCT01241305 -
One-Time DNA Study for Vasculitis
|
||
Completed |
NCT00748644 -
Efficacy Study of Two Treatments in the Remission of Vasculitis
|
Phase 3 | |
Recruiting |
NCT02967068 -
VCRC Tissue Repository
|
||
Completed |
NCT01731561 -
Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis
|
Phase 3 | |
Not yet recruiting |
NCT06350110 -
Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)
|
Phase 1/Phase 2 | |
Completed |
NCT02190942 -
VCRC Patient Contact Registry Patient-Reported Data Validation Study
|
||
Not yet recruiting |
NCT02126098 -
Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis
|
N/A | |
Terminated |
NCT01586858 -
Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study
|
N/A | |
Completed |
NCT00307593 -
RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides
|
N/A | |
Completed |
NCT02190929 -
Educational Needs of Patients With Systemic Vasculitis
|
N/A | |
Terminated |
NCT05376319 -
PR3-AAV Resilient Remission or PRRR
|
Phase 2 | |
Completed |
NCT02476292 -
Impact of Vasculitis on Employment and Income
|
N/A | |
Completed |
NCT02169219 -
Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis
|
Phase 4 | |
Completed |
NCT01613599 -
An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
|
||
Active, not recruiting |
NCT05716334 -
Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator
|
||
Completed |
NCT00307671 -
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years
|
Phase 4 |