Trial record 11 of 84 for:
Open Studies | "Vasculitis"
A Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With ANCA-Associated Renal Vasculitis
This study is currently recruiting participants.
Verified June 2012 by ChemoCentryx
Sponsor:
ChemoCentryx
Information provided by:
ChemoCentryx
ClinicalTrials.gov Identifier:
NCT01363388
First received: May 26, 2011
Last updated: June 30, 2012
Last verified: June 2012
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Purpose
The aim of this trial is to optimize the treatment to induce remission for patients with non-life-threatening anti-neutrophil cytoplasmic antibody renal vasculitis (AARV) with mild-to-moderate renal involvement. The intent is to reduce the toxicity of induction therapy by reducing the overall exposure to or eliminating entirely the use of systemic corticosteroids during the induction period with an inhibitor of the complement C5a receptor plus cyclophosphamide.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Vasculitis |
Drug: Placebo Drug: CCX168 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Renal Vasculitis on Background of Cyclophosphamide Treatment |
Resource links provided by NLM:
Further study details as provided by ChemoCentryx:
Primary Outcome Measures:
- Safety of CCX168 in subjects with AARV [ Time Frame: 169 days ] [ Designated as safety issue: Yes ]Safety assessments include adverse events, physical examination abnormalities, vital signs and clinical laboratory tests (including blood chemistry, hematology and urinalysis).
Secondary Outcome Measures:
- Systemic corticosteroid use [ Time Frame: 169 days ] [ Designated as safety issue: No ]Systemic corticosteroid use based on total oral corticosteroid dose and duration of oral corticosteroid use
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
BID for 84 days
|
|
Experimental: CCX168
Active study medication
|
Drug: CCX168
BID for 84 days
|
Detailed Description:
The primary objective of this study is to evaluate the safety and tolerability of CCX168 in subjects with AARV on background of cyclophosphamide treatment.
The secondary objectives of this study include assessment of the feasibility of reducing or eliminating the use of corticosteroids in the treatment of subjects with ANCA-associated renal vasculitis without the need for rescue corticosteroid measures and the effect of CCX168 on several disease parameters.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Clinical diagnosis of Wegener's granulomatosis, microscopic polyangiitis or renal limited vasculitis
- Male and postmenopausal or surgically sterile female subjects aged 18-75 years with new or relapsed AARV where treatment with cyclophosphamide would be required
- Positive indirect immunofluorescence (IIF) test for P-ANCA or C-ANCA, or positive ELISA test for anti-proteinase-3 (PR3) or anti-myeloperoxidase (MPO) at screening
- Proven to have renal vasculitis based on renal biopsy or hematuria and proteinuria compatible with nephritis
- Estimated glomerular filtration rate ≥ 30mL/min
Key Exclusion Criteria:
- Severe disease as determined by rapidly progressive glomerulonephritis, alveolar hemorrhage, hemoptysis, rapid-onset mononeuritis multiplex or central nervous system involvement
- Any other multi-system autoimmune disease
- Medical history of coagulopathy or bleeding disorder
- 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
- Received high-dose intravenous corticosteroids within 4 weeks of screening
- On an oral dose of a corticosteroid of more than 10mg prednisone-equivalent at the time of screening
- 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, IVIg or plasma exchange within 12 weeks of screening
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01363388
Show 35 Study Locations
Contacts
| Contact: Antonia Potarca | +31 630 892 290 | apotarca@chemocentryx.com |
Show 35 Study LocationsSponsors and Collaborators
ChemoCentryx
Investigators
| Study Director: | Pirow Bekker, MD, PhD | ChemoCentryx Inc |
More Information
No publications provided
| Responsible Party: | Senior VP Medical and Clinical Affairs, ChemoCentryx Inc |
| ClinicalTrials.gov Identifier: | NCT01363388 History of Changes |
| Other Study ID Numbers: | CL002_168 |
| Study First Received: | May 26, 2011 |
| Last Updated: | June 30, 2012 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products Czech Republic: State Institute for Drug Control Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Netherlands: Ministry of Health, Welfare and Sport Poland: Ministry of Health Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Vasculitis Vascular Diseases Cardiovascular Diseases Antibodies, Antineutrophil Cytoplasmic |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013