We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

RING - Rituximab for Lupus Nephritis With Remission as a Goal (RING)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01673295
First Posted: August 27, 2012
Last Update Posted: May 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain
  Purpose

OBJECTIVE To test whether Rituximab (RTX) is efficacious to achieve complete renal response (CR) in Lupus Nephritis (LN) patients with persistent proteinuria (≥1g/d) despite at least 6 months of standard of care (SOC).

STUDY DESIGN Investigator-initiated randomized international open multicentric 104-week study.


Condition Intervention Phase
Lupus Nephritis Drug: RTX infusions Other: Standard of Care Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RING - Rituximab for Lupus Nephritis With Remission as a Goal, an Investigator-initiated Randomized International Open Multicentric Study

Resource links provided by NLM:


Further study details as provided by Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain:

Primary Outcome Measures:
  • The primary endpoint is the percentage of patients achieving renal complete response (CR) at w104. [ Time Frame: 104 weeks ]

    CR is defined as :

    • uP/C ratio ≤0.5 (expressed in mg/mg) measured in a 24-h urine collection; and
    • eGFR >=60ml/min or, if <60ml/min at screening, not fallen by >20% compared to screening; and
    • no increase of glucocorticoïds (GC) throughout the study (except for two limited courses as per protocol; vide infra); and
    • no introduction of another immunosuppressant.


Estimated Enrollment: 194
Study Start Date: November 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RTX group
Subjects will receive a RTX infusion (1g) at w0, w2, w24, w48 and w72.
Drug: RTX infusions
RTX + Standard of Care
Active Comparator: Control group
Subjects will not receive RTX infusions and will be followed in standard of care
Other: Standard of Care
Standard of Care only

Detailed Description:

After screening (week -8), patients enter in a run-in period of 6 weeks during which treatment is unchanged. At week -2, if persistent proteinuria is confirmed (uP/C ratio ≥1 expressed in mg/mg), patients will be randomized in a 1/1 ratio to 1 of 2 treatment groups as follows :

RTX group Subjects will receive a RTX infusion (1g) at w0, w2, w24, w48 and w72.Control group Subjects will not receive RTX infusions. In both arms, azathioprine (AZA) or mycophenolate mofetil (MMF) will be continued. If prescribed, prednisolone dose should not be > 10 mg/day.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All the following inclusion criteria are to be met :

  1. SLE, according to ACR and/or SLICC (Arthritis Rheum 2012; May 2; doi: 10.1002/art.34473) criteria ;
  2. Age ≥15y (except if local ethics committee imposes ≥18y) ;
  3. ISN/RPS 2003 Class III (A or A/C), IV (A or A/C ; S or G) or V lupus GN confirmed on renal biopsy performed within 24 months before screening ;
  4. Having received one out of four following immunosuppressive regimens:

    i): Euro-Lupus (EL) intravenous (IV) cyclophosphamide (CY) (6x 500 mg q2w) followed by AZA/MMF for 3 months ; ii): NIH IVCY for 6M (6 monthly pulses) followed by AZA/MMF for 3 months ; iii): MMF for at least 6 months at a dose of 2g/day (or the maximal tolerated dose; iv): AZA for at least 6 months at a dose of 2 mg/kg/day (or the maximal toerated dose).

    All patients should be on AZA or MMF at screening. In all regimens, MMF can be replaced by enteric-coated mycophenolic acid (eMPA) ;

  5. If on GC, being on maximum 10 mg equivalent prednisolone/d at screening (for at least 2 weeks) ;
  6. uP/C ratio ≥1 (expressed in mg/mg) measured in a 24-h urine collection, confirmed at randomization (w-2) ;
  7. Contraception (any type ; sexual abstinence is an alternative to contraception in paediatric patients) ;
  8. Signed informed consent (drafted according to local practice and approved by the local ethics committee).

Exclusion Criteria:

Any of the following :

  1. Recent or ongoing renal flare defined as either i) : fall in estimated glomerular filtration rate (eGFR ; MDRD) ≥25% within 3 month prior to screening or between screening and randomization ; or ii) : increase in urine protein by ≥100% to >3.5g/d compared to previous assessment ;
  2. 24-h proteinuria decline >50% over previous 6 months ;
  3. Treatment with ≥10 mg equivalent prednisolone/d in the last 2 weeks before screening ;
  4. Pregnancy or breast-feeding ;
  5. Anticipated non-compliance with the protocol ;
  6. History of malignancy (except non-melanoma skin and cervical intraepithelial cancer) ;
  7. Previous treatment with RTX (whenever) and previous treatment with another biologic agent within the last 6 months ;
  8. HIV infection ;
  9. Active HBV/HCV/TB infection ;
  10. Severe liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, haematologic or psychiatric disturbances, that would contraindicate inclusion in the protocol, as judged by the clinician.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673295


Contacts
Contact: Frédéric A Houssiau, MD PHD +32 2 7645391 frederic.houssiau@uclouvain.be
Contact: Geneviève J Depresseux, Trial Coord +32 2 7645395 genevieve.depresseux@uclouvain.be

Locations
Belgium
Cliniques Universitaires Saint Luc Recruiting
Bruxelles, Belgium, 1200
Contact: Frédéric A Houssiau, MD PHD    +32 2 7645391    frederic.houssiau@uclouvain.be   
Contact: Geneviève J Depresseux, Trial Coord    +32 2 7645395    genevieve.depresseux@uclouvain.be   
Principal Investigator: Frédéric A Houssiau, MD PHD         
Sponsors and Collaborators
Frédéric A. Houssiau, MD, PhD
Investigators
Principal Investigator: Frédéric A Houssiau, MD PHD Cliniques universitaires Saint-Luc
  More Information

Responsible Party: Frédéric A. Houssiau, MD, PhD, Professeur Ordinaire, Chef de Service Clinique, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01673295     History of Changes
Other Study ID Numbers: P1200_11
First Submitted: August 22, 2012
First Posted: August 27, 2012
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain:
Lupus Nephritis
Rituximab

Additional relevant MeSH terms:
Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents