RING - Rituximab for Lupus Nephritis With Remission as a Goal

NCT01673295 | Unknown Phase 3 DMC

• 1 other identifier: P1200_11
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lupus Nephritis

Keywords

Lupus Nephritis; Rituximab

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the percentage of patients achieving renal complete response (CR) at w104.

  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.

  104 weeks

Study Arms (2)

RTX group

EXPERIMENTAL

Subjects will receive a RTX infusion (1g) at w0, w2, w24, w48 and w72.

Drug: RTX infusions

Control group

ACTIVE COMPARATOR

Subjects will not receive RTX infusions and will be followed in standard of care

Other: Standard of Care

Interventions

RTX infusions DRUG

RTX + Standard of Care

RTX group

Standard of Care OTHER

Standard of Care only

Control group

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ;
• 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).

You may not qualify if:

• 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 ;
• 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 ;

Sponsors & Collaborators

• Frédéric A. Houssiau, MD, PhD: lead

Study Sites (1)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Frédéric A Houssiau, MD PHD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric A Houssiau, MD PHD

CONTACT

+32 2 7645391; frederic.houssiau@uclouvain.be

Geneviève J Depresseux, Trial Coord

CONTACT

+32 2 7645395; genevieve.depresseux@uclouvain.be

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professeur Ordinaire, Chef de Service Clinique

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 27, 2012
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2016
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

BE (1)