Study to evaluate the safety and efficacy of CCX168 in subjects with renal vasculitis on background cyclophosphamide treatment

Phase 2

Completed

• Conditions: Renal Vasculitis; Circulatory System; Renal vasculitis

• Registration Number: ISRCTN53663626
• Lead Sponsor: ChemoCentryx, Inc. (USA)

Brief Summary

1. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28400446 (added 21/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-25
• Study Completion: 2013-03-31
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Clinical diagnosis of Wegener?s granulomatosis, microscopic polyangiitis or renal limited vasculitis
2. Male and postmenopausal or surgically sterile female subjects, aged 18-75 years with new or relapsed ANCA-associated renal vasculitis (AARV) where treatment with cyclophosphamide would be required
3. Positive indirect immunofluorescence (IIF) test for peri-nuclear (protoplasmic-staining) antineutrophil cytoplasmic antibodies (P-ANCA) or C-ANCA, or positive Enzyme-linked immunosorbent assay (ELISA) test for anti-proteinase-3 (PR3) or anti-myeloperoxidase (MPO) at screening
4. Proven to have renal vasculitis based on renal biopsy or have hematuria and proteinuria compatible with nephritis
5. Estimated glomerular filtration rate of greater than 30 mL per minute

Exclusion Criteria

1. Severe disease as determined by rapidly progressive glomerulonephritis, alveolar hemorrhage, hemoptysis, rapid-onset mononeuritis multiplex or central nervous system involvement
2. Any other multi-system autoimmune disease
3. Medical history of coagulopathy or bleeding disorder
4. Received cyclophosphamide within 12 weeks of screening; if on azathioprine, mycophenolate mofetil, or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the cyclophosphamide dose on Day 1
5. Received high-dose intravenous corticosteroids within 4 weeks of screening
6. On an oral dose of a corticosteroid of more than 10 mg prednisone-equivalent at the time of screening
7. Received rituximab or other B-cell antibody within 52 weeks of screening or 26 weeks provided B cell reconstitution has occurred; received anti-TNF treatment, abatacept, alemtuzumab, intravenous immunoglobulin (IVIg), or plasma exchange within 12 weeks of screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of CCX168 in patients with anti-neutrophil cytoplasmic antibody associated renal vasculitis measured upon completion of 84 days of treatment.

Secondary Outcome Measures

Name	Time	Method
Systemic corticosteroid use measured upon completion of 84 days of treatment.