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Pexivas protocol synopsis version 2

Protocol Version 2.0 Synopsis
Plasma exchange and glucocorticoid dosing in anti-neutrophil cytoplasm antibody associated vasculitis: a randomized controlled trial. PEXIVAS Cambridge University Hospitals NHS Foundation Trust Multi-centre, international, open label, factorial design, randomized control trial in severe ANCA-associated vasculitis (AAV). Five hundred participants will be randomized, 1:1, to receive adjunctive plasma exchange (PLEX) in addition to standard immunosuppressive therapy and glucocorticoids (GC) or standard immunosuppressive therapy and GC without PLEX. There will be a minimum duration of follow-up of 2 years. Randomisation is via the internet, using a computer generated minimization algorithm. Synopsis PEXIVAS Protocol Version 2.0 Version 1.0 March 2013 Inclusion Criteria

Patients must meet all of the following criteria:
1. New or previous relapsing clinical diagnosis of granulomatosis with polyangiitis (Wegener’s), or microscopic polyangiitis consistent with the Chapel-Hill consensus definitions (see 7.13.5) AND 2. Positive test, at any point in the subjects’s disease course, by ELISA, for proteinase 3-ANCA or myeloperoxidase-ANCA AND 3. Severe vasculitis defined by at least one of the following manifestations: a. Renal involvement characterized by both of the following: i. Evidence of glomerulonephritis by either of the following: 1. Renal biopsy demonstrating focal necrotizing 2. Active urine sediment characterized by glomerular haematuria/cellular casts and proteinuria ii. An estimated glomerular filtration (eGFR) rate of <50 ml/min/1.73 m2. Patients known to have a stable eGFR <50 ml/min/1.73 m2 for greater than three months prior to enrollment are NOT eligible. b. Pulmonary hemorrhage due to active vasculitis defined by the Synopsis PEXIVAS Protocol Version 2.0 Version 1.0 March 2013 i. A compatible chest x-ray or CT scan (diffuse pulmonary ii. The absence of an alternative explanation for all pulmonary infiltrates (i.e. volume overload or pulmonary infection) 1. Evidence of alveolar hemorrhage on bronchoscopic examination or increasingly bloody returns with bronchoalveolar lavage 2. Observed hemoptysis 3. Unexplained anemia (<10 g/dL) or documented drop in hemoglobin (>1 g/dL) from less than 10g/dl 4. An increased diffusing capacity of carbon dioxide 4. Provision of informed consent by patient or a surrogate decision maker. In some participating countries permission has also been granted to use deferred consent for enrolling a patient until a legal representative becomes available to consent on their behalf. Please check your national regulations for further guidance. Exclusion Criteria

Patients must have none of the following:
1. A diagnosis of vasculitis other than granulomatosis with polyangiitis (Wegener’s) or microscopic polyangiitis 2. A positive serum test for anti-glomerular basement membrane or a renal biopsy demonstrating linear glomerular immunoglobulin deposition 3. Receipt of dialysis for greater than 21 days immediately prior to 4. Age <15 years. In centres that do not routinely treat patients <18 years or if no local investigator routinely treats patients <18 years, enrollment may be restricted to patients 18 years or older* 5. Pregnant at time of study entry 6. Treatment with >1 IV dose of cyclophosphamide and/or >14 days of oral cyclophosphamide and/or >14 days of prednisone/prednisolone (>30 mg/day) and/or treatment with >1 dose of rituximab within the last 28 days 7. A comorbidity or condition that, in the opinion of the investigator, precludes the use of cyclophosphamide/rituximab, glucocorticoids, or plasma exchange or absolutely mandates the use of plasma exchange 8. Plasma exchange in 3 months prior to randomization Synopsis PEXIVAS Protocol Version 2.0 Version 1.0 March 2013 Treatment descriptuion

Plasma Exchange Induction Therapy

PLEX will consist of 7 exchanges within 14 days of randomization, of at least 60
ml/kg (based on actual body weight) per session using albumin (3% to 5% depending
on local availability, with or without crystalloid) as a replacement solution. The
minimum replacement solution volume is 3000 ml. Intravenous immunoglobulin
should not be used after PLEX.
The following parameters may be determined according to local practice:
1) PLEX may be performed by centrifugation or filter separation technique, double
filtration apheresis (DFA) is not permitted
2) Anticoagulation may be provided by citrate or by heparin but it is suggested that in
patients with active bleeding regional citrate anticoagulation be utilized,
3) PLEX may be performed via a central venous catheter if patient is deemed
unsuitable for peripheral venous access, the latter is strongly recommended, and
4) Monitoring of coagulation parameters or immunoglobulin levels, and
5) PLEX dose may be reduced for PLEX related complications according to local best
medical practice and indication and dose alteration noted for future analysis.
Glucocorticoids Therapy

Patients Who Have Not Received Any Glucocorticoid Therapy Prior To
GC therapy shall commence with intravenous (IV) methylprednisolone irrespective of
the GC group the patient is allocated to. IV methylprednisolone shall be given as three
daily pulse doses (minimum 1g maximum 3g, total dose). Each pulse dose may be
between 0.5 g and 1 g at the local investigators discretion. The day following the last
IV methylprednisolone dose, patients will commence the randomized oral GC
Patients Who Have Received <3 g IV Methylprednisolone Within 14 days Prior
To Randomization
IV methylprednisolone administered within 14 days prior to randomization will
contribute to the maximum allowable dose of 3g. If <3 g of IV methylprednisolone
were given within 14 days prior to randomization, participants may receive additional
IV methylprednisolone over 3 days after randomization to reach a minimum of 1 g
and a maximum of 3 g (including all IV methylprednisolone given within 14 days
prior to randomization). The day following the last IV methylprednisolone dose,
patients will commence the randomized oral GC regimen.
Synopsis PEXIVAS Protocol Version 2.0 Version 1.0 March 2013 Patients Who Have Received Oral GC But No IV Methylprednisolone Within 14
Days Prior to Randomization
Oral GC given prior to randomization do not impact on the protocol GC regimen in
terms of either IV methylprednisolone or oral GC. These patients should be treated as
if they had not received any GC prior to randomization.
Patients Who Have Received ≥3 g Of IV Methylprednisolone Within 14 Days
Prior to Randomization
Patients that have received ≥3 g IV methylprednisolone within 14 days prior to
randomization should begin the oral GC regimen according to their randomized group
within 24 hours of randomization.

Immunosuppressive Remission-Induction Therapy

Consist of either cyclophosphamide or rituximab, as per preference of site

Follow-up Schedule

Baseline, PLEX visit (if randomised to PLEX), then at 2, 4, 8 and 12 weeks, end of
induction (between weeks 13 and 26), 26 and 52 weeks, and then every 26 weeks
thereafter for at least 2 years (maximum follow-up is 7 years).
Outcome measures

All-cause mortality or end-stage renal disease (ESRD) Sustained remission; all-cause mortality; ESRD; serious adverse events; serious infections, quality of life (using Short Form – 36 (SF-36) and EuroQoL EQ5D Index Score). Synopsis PEXIVAS Protocol Version 2.0 Version 1.0 March 2013


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