Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
ANCA-associated renal vasculitis (AARV) is an autoimmune disease involving multiple organs including the kidneys. It is caused by abnormal antibodies (autoantibodies) that attack a certain type of white blood cells (neutrophils) and can cause those neutrophils to stick to and destroy the inside walls of small blood vessels in tissue and organs such as the kidney. ANCA is an acronym for Anti-Neutrophil Cytoplasmic Antibody.
The aim of this study is to test a newly developed drug (oral investigational product CCX168) for safety and tolerability while you continue to receive the ‘standard of care’ cyclophosphamide treatment, and varying doses of prednisone or prednisone placebo.

Who can participate?
Patients aged 18-75 who are experiencing a recent relapse or new diagnosis of ANCA-associated renal vasculitis.

What does the study involve?
Some patients will receive capsules of CCX168 or placebo, and capsules of prednisone or prednisone-placebo daily for a period of 84 days. This is in addition to their ‘standard of care’ intravenous cyclophosphamide treatment.

What are the possible benefits and risks of participating?
If successful, CCX168 could possibly allow for lower dosing or complete elimination of high dose corticosteroid treatment in this disease. As a result patients with this disease may have less of the toxic side effects usually caused by high dose corticosteroids. CCX168 appeared to be well tolerated in Phase I studies with healthy subjects and adverse events were mild in nature. All new drugs (investigational compounds) have the potential for unanticipated serious or life-adverse events. These side effects could be in addition to the well documented side effects of cyclophosphamide and high dose corticosteroid ‘standard of care’ treatments.

Where is the study run from?
There are about 40 sites participating in this study. They are located in Belgium, Czech Republic, Germany, Hungary, the Netherlands, Poland, Sweden and the UK. The lead study center is at Addenbrooke’s Hospital, Department of Nephrology at Cambridge in the UK.

When is the study starting and how long is it expected to run for?
Patient screening and dosing are scheduled to begin in the fall of 2011 completing in December 2012.

Who is funding the study?
ChemoCentryx (USA)

Who is the main contact?
Antonia Potarca

Trial website

Contact information



Primary contact

Dr David Jayne


Contact details

Addenbrooke's Hospital
Hills Road
Department of Nephrology
United Kingdom

Additional identifiers

EudraCT number number


Protocol/serial number


Study information

Scientific title

A randomized, double-blind, placebo-controlled, phase 2 study to evaluate the safety and efficacy of CCX168 in subjects with renal vasculitis on background cyclophosphamide treatment


CLEAR (C5aR inhibitor on Leukocytes Exploratory ANCA-associated Renal vasculitis study)

Study hypothesis

That CCX168, a C5a complement receptor, will be safe, well tolerated and effective in patients with antineutrophil cytoplasmic antibodies ANCA-associated renal vasculitis on background cyclophosphamide treatment and may result in reduced toxicity of induction therapy by the reduction of or the elimination of systemic corticosteroid therapy.

Ethics approval

NRES Committee East of England-Cambridge Central, 13/10/2011, ref: 11/EE/0210
All other centres will seek ethics approval before recruitment of the first participant

Study design

Multi-centre randomized double-blind placebo-controlled phase 2 study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Renal Vasculitis


1. Treatment: CCX168 30mg or placebo twice daily for 84 days
2. Comparator: Prednisone at starting doses ranging from 15 to 60 mg (body weight dependent) per day for 84 days or matching prednisone placebo once daily for 84 days

Intervention type



Phase II

Drug names

CCX168, prednisone, cyclophosphamide

Primary outcome measures

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

Secondary outcome measures

Systemic corticosteroid use measured upon completion of 84 days of treatment.

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants

Approximately 60

Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

Belgium, Czech Republic, Germany, Hungary, Netherlands, Poland, Sweden, United Kingdom

Trial participating centre

Addenbrooke's Hospital
United Kingdom

Sponsor information


ChemoCentryx, Inc. (USA)

Sponsor details

850 Maude Avenue
Mountain View
United States of America

Sponsor type




Funder type


Funder name

ChemoCentryx, Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/03/2016: No publications found, verifying study status with principal investigator