Lupus NephritisPhase 3RINGNCT01673295
RING - Rituximab for Lupus Nephritis With Remission as a Goal
A Phase 3 study testing RTX infusions in people with Lupus Nephritis, run by Frédéric A. Houssiau, MD, PhD at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- RTX infusions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2014to Nov 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 ;
- 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).
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- 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).
Who cannot join
- 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 ;
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- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint Luc
Brussels, 1200
Frédéric A Houssiau, MD PHD, +32 2 7645391, frederic.houssiau@uclouvain.be
Geneviève J Depresseux, Trial Coord, +32 2 7645395, genevieve.depresseux@uclouvain.be
About this study
Official title: RING - Rituximab for Lupus Nephritis With Remission as a Goal, an Investigator-initiated Randomized International Open Multicentric Study
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.
Read the 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.
- Conditions
- Lupus Nephritis
- Being tested
- RTX infusions, Standard of Care
- Keywords
- Lupus Nephritis, Rituximab
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTX infusionsDrug
RTX + Standard of Care
Standard of CareOther
Standard of Care only
| Study group | Role | What they receive |
|---|---|---|
| RTX group | Experimental | Subjects will receive a RTX infusion (1g) at w0, w2, w24, w48 and w72. Receives: Drug: RTX infusions |
| Control group | Active comparator | Subjects will not receive RTX infusions and will be followed in standard of care Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startNov 2014
- Primary completionNov 2015 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frédéric A. Houssiau, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Frédéric A. Houssiau, MD, PhD, Université Catholique de Louvain
- Investigators
- Frédéric A Houssiau, MD PHD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673295
- Sponsor's protocol ID
- P1200_11
- Acronym
- RING
- Status last verified
- May 2015
- First submitted
- 22 Aug 2012
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RING - Rituximab for Lupus Nephritis With Remission as a Goal, an Investigator-initiated Randomized International Open Multicentric Study
- ClinicalTrials.gov ID
- NCT01673295
- Acronym / sponsor ID
- RING / P1200_11
- Conditions
- Lupus Nephritis
- Keywords
- Lupus Nephritis, Rituximab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Frédéric A. Houssiau, MD, PhDUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 27 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RTX group | Experimental | Drug: RTX infusionsSubjects will receive a RTX infusion (1g) at w0, w2, w24, w48 and w72. |
| Control group | Active comparator | Other: Standard of CareSubjects will not receive RTX infusions and will be followed in standard of care |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (11 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RTX infusionsRTX + Standard of Care | Drug | RTX group |
| Standard of CareStandard of Care only | Other | Control group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric A Houssiau, MD PHD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RTX infusions in people with Lupus Nephritis, run by Frédéric A. Houssiau, MD, PhD at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frédéric A Houssiau, MD PHD (+32 2 7645391, frederic.houssiau@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the percentage of patients achieving renal complete response (CR) at w104. (time frame: 104 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.