Plasma Exchange for Renal Vasculitis (MEPEX)
This study has been terminated.
(Completed)
Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborators:
University Hospital Birmingham
Imperial College London
North West London Hospitals NHS Trust
University Hospitals, Leicester
Lund University Hospital
University Medical Centre Groningen
Fundacio Clinic
Helsinki University
Information provided by:
Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01408836
First received: August 2, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to test whether additional therapy with plasma exchange improves the chances of kidney recovery in severe kidney vasculitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Wegener's Granulomatosis Microscopic Polyangiitis |
Procedure: Plasma exchange Drug: Intravenous methyl prednisolone Drug: Methyl prednisolone |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomised Trial of Plasma Exchange or High Dose Methyl Prednisolone as Adjunctive Therapy for Severe Renal Vasculitis |
Resource links provided by NLM:
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
U.S. FDA Resources
Further study details as provided by Cambridge University Hospitals NHS Foundation Trust:
Primary Outcome Measures:
- Renal recovery [ Time Frame: Three months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- End stage renal disease at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Serum creatinine at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Severe adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 150 |
| Study Start Date: | March 1995 |
| Study Completion Date: | December 2003 |
| Primary Completion Date: | June 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Plasma exchange x 7 over 14 days
|
Procedure: Plasma exchange
Plasma exchange
|
|
Active Comparator: 2
Methyl prednisolone 1g x 3
|
Drug: Intravenous methyl prednisolone
Intravenous methyl prednisolone
Drug: Methyl prednisolone
methyl prednisolone
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of Wegener's granulomatosis or microscopic polyangiitis, using criteria adapted by EUVAS from the disease definitions of the Chapel Hill consensus conference
- Biopsy proven, pauci-immune, necrotising and/or crescentic glomerulonephritis, in the absence of other defined glomerulopathy
- Severe renal impairment defined by: (i) oliguria (<400ml/24hr), or (ii) intention to commence dialysis within 48 hours of admission, and (iii) creatinine >500umol/l (5.8mg/dl).
Exclusion Criteria:
- Age under 18 or over 80 years
- Inadequate contraception in women of child-bearing age
- Pregnancy
- Previous malignancy
- Hepatitis B antigenaemia, anti-hepatitis C virus or anti-human immunodeficiency virus antibody
- Diagnosis of Churg-Strauss syndrome, Henoch-Schönlein purpura, rheumatoid vasculitis, mixed essential cryoglobulinaemia or systemic lupus erythematosus
- Circulating anti-GBM antibodies or linear IgG staining of the GBM on renal biopsy
- Life-threatening non-renal manifestations of vasculitis, including alveolar hemorrhage requiring mechanical ventilation within 24 hours of admission
- On dialysis for > two weeks prior to entry
- Creatinine > 200umol/l (2.3mg/dl) one year or more before entry
- A second clearly defined cause of renal failure
- Previous episode of biopsy-proven necrotising and/or crescentic glomerulonephritis
- > two weeks treatment with cyclophosphamide or azathioprine
- > 500mg IV methyl prednisolone
- Plasma exchange within the preceding year
- > three months treatment with oral prednisolone
- Allergy to study medications.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408836
Locations
| United Kingdom | |
| Addenbrooke's Hospital | |
| Cambridge, United Kingdom, CB22QQ | |
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
University Hospital Birmingham
Imperial College London
North West London Hospitals NHS Trust
University Hospitals, Leicester
Lund University Hospital
University Medical Centre Groningen
Fundacio Clinic
Helsinki University
Investigators
| Study Director: | Niels Rasmussen, MD | Righospitalet, Copenhagen, Denmark |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT01408836 History of Changes |
| Other Study ID Numbers: | BMH4-CT97-2328 |
| Study First Received: | August 2, 2011 |
| Last Updated: | August 2, 2011 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Cambridge University Hospitals NHS Foundation Trust:
|
Vasculitis ANCA Therapy Plasma exchange Immunosuppression |
Additional relevant MeSH terms:
|
Vasculitis Wegener Granulomatosis Systemic Vasculitis Microscopic Polyangiitis Vascular Diseases Cardiovascular Diseases Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Immune System Diseases Methylprednisolone acetate Prednisolone acetate Methylprednisolone |
Methylprednisolone Hemisuccinate Prednisolone Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013