Clinical trial to study a drug in people with kidney disease related to lupus
- Conditions
- Patients with ISN/RPS or WHO class III or IV Active Lupus NephritisMedDRA version: 15.1Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2006-005357-29-BG
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 369
Patients must meet the following criteria to be eligible for study entry. Documentation of each specific criterion must be present in the patient’s chart notes:
1. Age 16 years or above at the time of the screening unless the inclusion of minors is prohibited by the local regulations.
2. Ability and willingness to provide written informed consent (or to obtain consent from a parent guardian where applicable) and to comply with the schedule of protocol requirements.
3. Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE. The 4 criteria do not have to be present at the time of screening.
4. Active lupus nephritis defined as follows: Biopsy proven (within 6 months prior to randomization) WHO or ISN Class III or IV LN (excluding III (C), IV-S (C) and IV-G (C),
Patients are permitted to have co-existing Class V. Whenever possible, biopsies should be graded and reported following ISN/RPS classification scheme. In cases where this is not possible, it is acceptable to include patients with WHO class III or IV GN, provided
that no more than 50% of glomeruli show sclerosis or fibrosis (see Exclusion
Criterion # 2).
AND
The presence of: Urinary protein to Urinary creatinine ratio = 1. The proteinuria
must not have improved by = 50% in the preceding 6 months.
The urine sample used to define this ratio is the 24 hour screening sample which
is measured by the central laboratory. If collection and analysis of a 24 hour
urine sample is not possible prior to randomization then a timed urine collection
(at least 12 hours) should be obtained.
Determination of eligibility based on a first-void morning ‘spot’ urine sample is
acceptable if collection and analysis of a timed urine sample is not possible prior
to randomization.
5. For patients of reproductive potential (males and females), a reliable means of contraception must be used for the duration of the study (e.g. hormonal contraceptive, intrauterine device, physical barrier) according to local guidelines and the treating physician’s recommendations. The relevant section of the product label for CYC, MMF or AZA (as appropriate) should be followed.
6. Female patients of childbearing potential must have a negative serum pregnancy test from the screening visit prior to enrollment at Day 1.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusions Related to SLE
1. Currently active retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia or dementia.
2. Severe renal impairment as defined by calculated (by Cockcroft-Gault) GFR < 25 mL/min, or the presence of oliguria (defined as a documented urine volume
< 400 mL/24hr) or renal biopsy results indicating chronic irreversible renal scarring (either > 50% of glomeruli with sclerosis or > 50% interstitial fibrosis on renal biopsy).
Exclusions Related to General Health
3. Lack of peripheral venous access.
4. Pregnancy or breast feeding mothers.
5. History of severe allergic or anaphylactic reactions to humanized, chimeric or murine monoclonal antibodies or i.v. immunoglobulin.
6. Known severe chronic pulmonary disease (FEV1 < 50% predicted or functional dyspnea = Grade 3 on the MRC Dyspnea Scale).
7. Evidence of significant uncontrolled concomitant diseases in any organ system not related to SLE (e.g. renal thrombosis, atherosclerotic cardiovascular disease, diabetes mellitus, accelerated hypertension, poorly controlled COPD or asthma
etc), which, in the investigator’s opinion, would preclude patient participation.
8. Concomitant condition (e.g. asthma, Crohn’s disease, etc) which has required treatment with systemic corticosteroid (excluding topical or inhaled steroids) at any time in the 52 weeks prior to screening.
9. Known HIV or chronic active Hepatitis B or chronic active Hepatitis C infection.
10. Known active clinically significant infection of any kind (with the exception of
fungal infection of nail beds or oral thrush) or any major episode of infection
requiring hospitalization or treatment with intravenous anti-infectives in the
14 days prior to Day 1. Patients may be enrolled in the presence of recent minor
infections not requiring treatment with anti-infectives (e.g. viral upper
respiratory tract infection, viral gastroenteritis), if in the investigator’s opinion,
the infection has resolved prior to Day 1 and is unlikely to present additional
risk to the subject.
11. History of serious recurrent or chronic infection. A chest radiograph will be performed during screening, if not performed in the 12 weeks prior to screening, to assess infection. If there is any evidence of pulmonary infection a chest radiograph should be performed.
12. History of cancer, including solid tumors, hematological malignancies and carcinoma in situ (except basal cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured).
13. History of alcohol or drug abuse in the 52 weeks prior to screening.
14. Major surgery in the 4 weeks prior to screening, excluding diagnostic surgery.
Exclusions Related to Medications
15. Previous treatment with CAMPATH-1H.
16. Previous treatment with a BAFF directed treatment (e.g. anti-BLyS) in the 12 months prior to screening.
17. Previous treatment with a B-cell targeted therapy (e.g. anti-CD20, anti-CD22 other than one directed at BAFF ).
18. Treatment with any investigational agent in the 28 days prior to screening or within five half-lives of the investigational drug (whichever is longer).
19. Receipt of any live vaccines in the 6 weeks prior to Day 1 (it is recommended that a patient’s vaccination record and the need for immunization prior to receiving ocrelizumab should be carefully investigated).
20. Intolerance or contraindication to oral or i.v. corticosteroids
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method