RING - Rituximab for Lupus Nephritis With Remission as a Goal (RING)
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ClinicalTrials.gov Identifier: NCT01673295 |
Recruitment Status
: Unknown
Verified May 2015 by Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain.
Recruitment status was: Recruiting
First Posted
: August 27, 2012
Last Update Posted
: May 28, 2015
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Lupus Nephritis | Drug: RTX infusions Other: Standard of Care | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 194 participants |
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 |
Study Start Date : | November 2014 |
Estimated Primary Completion Date : | November 2015 |
Estimated Study Completion Date : | November 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: RTX group
Subjects will receive a RTX infusion (1g) at w0, w2, w24, w48 and w72.
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Drug: RTX infusions
RTX + Standard of Care
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Active Comparator: Control group
Subjects will not receive RTX infusions and will be followed in standard of care
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Other: Standard of Care
Standard of Care only
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- 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.

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Ages Eligible for Study: | 15 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All the following inclusion criteria are to be met :
- SLE, according to ACR and/or SLICC (Arthritis Rheum 2012; May 2; doi: 10.1002/art.34473) criteria ;
- Age ≥15y (except if local ethics committee imposes ≥18y) ;
- 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 ;
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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) ;
- If on GC, being on maximum 10 mg equivalent prednisolone/d at screening (for at least 2 weeks) ;
- uP/C ratio ≥1 (expressed in mg/mg) measured in a 24-h urine collection, confirmed at randomization (w-2) ;
- Contraception (any type ; sexual abstinence is an alternative to contraception in paediatric patients) ;
- Signed informed consent (drafted according to local practice and approved by the local ethics committee).
Exclusion Criteria:
Any of the following :
- 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 ;
- 24-h proteinuria decline >50% over previous 6 months ;
- Treatment with ≥10 mg equivalent prednisolone/d in the last 2 weeks before screening ;
- Pregnancy or breast-feeding ;
- Anticipated non-compliance with the protocol ;
- History of malignancy (except non-melanoma skin and cervical intraepithelial cancer) ;
- Previous treatment with RTX (whenever) and previous treatment with another biologic agent within the last 6 months ;
- HIV infection ;
- Active HBV/HCV/TB infection ;
- Severe liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, haematologic or psychiatric disturbances, that would contraindicate inclusion in the protocol, as judged by the clinician.

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
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 |
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 |
Principal Investigator: | Frédéric A Houssiau, MD PHD | Cliniques universitaires Saint-Luc |
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 Posted: | August 27, 2012 Key Record Dates |
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 |