Systemic Lupus Erythematosus, Lupus NephritisPhase 3RITUXILUPNCT01773616
Trial of Rituximab and Mycophenolate Mofetil Without Oral Steroids for Lupus Nephritis
A Phase 3 study testing Oral prednisolone, Rituximab and Mycophenolate mofetil in people with Systemic Lupus Erythematosus, Lupus Nephritis, run by Imperial College London at 11 sites in United Kingdom.
Trial summary
The treatment of the multisystem autoimmune disease systemic lupus erythematosus (SLE) remains a challenge, particularly when there is renal involvement (lupus nephritis). For the last 60 years corticosteroids have been the backbone of the treatment of lupus nephritis but they are associated with significant toxicity. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Lupus Nephritis
- What is being tested?
- Oral prednisolone, Rituximab and Mycophenolate mofetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 11 sitesUnited Kingdom
- Study dates
- Apr 2015to Dec 2017
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Obsolescence of >50% of the glomeruli or tubulointerstitial scarring of >50% or cellular crescents in >50% of the glomeruli
- Severe "critical" SLE flare defined as:
- BILAG 2004 A flare in CNS system
- or any SLE manifestation requiring more immunosuppression than allowed within the protocol in the physician's opinion
- Pregnant or lactating. Woman who have child bearing potential must have two negative pregnancy test results with a sensitivity of ≥ 25 mIU/mL: one from a serum pregnancy test at day -8 to day -10 of screening and another from a urine pregnancy test at day 1 prior to randomisation. If the timeline is shortened because of clinical urgency, then there must be a negative serum pregnancy test with a sensitivity of ≥ 25 mIU/mL within 1-2 days before study start
- Patients not willing for their GP to be informed of their participation in this study
Show all 19Show fewer
- Patients should not be on or require maintenance steroids and should not have had more than 12 weeks of steroids in the period immediately preceding recruitment irrespective of dose
- Patients that had received more than 2.0g of IV methyl prednisolone in the previous 4 weeks
- Prior use within 12 months of screening visit of therapeutic monoclonal antibody, or B or T cell modulating 'biologic' use
- Prior use within 6 months of the screening visit of Intravenous immunoglobulin / plasma exchange OR Cyclophosphamide
- Active infections, including but not limited to the human immunodeficiency virus (HIV), and hepatitis B (including prior infection as judged by positive Hepatitis B core antibody) or Hepatitis C or tuberculosis
- Receipt of a live-attenuated vaccine within 3 months of study enrolment
- In the investigator's opinion, patients that are at high risk for infection (including but not limited to indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent severe urinary tract infection)
- Prior history of invasive fungal infections
- History of any cancer
- In female patients, known history of cervical dysplasia CIN Grade III cervical high risk human papillomavirus or abnormal cervical cytology other than abnormal squamous cells of undetermined significance (ASCUS) within the past 3 years. The patient will be eligible after the condition has resolved (e.g., follow-up HPV test is negative or cervical abnormality has been effectively treated >1 year ago)
- Any concomitant medical condition or abnormal blood results that in the investigator's opinion, or after discussion with the CI, places the participant at risk by participating in this study.
- Comorbidities requiring systemic corticosteroid therapy.
- Current substance abuse.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United Kingdom11 sites
Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
Chapel Allerton Hospital, The Leeds Teaching Hospitals NHS Trust
Leeds, LS7 4SA
Leicester General Hospital, University Hospitals of Leicester NHS Trust
Leicester, LE5 4PW
Royal Free London NHS Foundation Trust
London, NW3 2QG
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, W12 0HS
Great Ormond Street Hospital for Children NHS Foundation Trust
London, WC1N 3JN
King's College Hospital
London
Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust
Manchester, M13 9WL
Churchill Hospital, Oxford University Hospitals NHS Trust
Oxford, OX3 7LE
Royal Stoke Hospital, University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, ST4 6QG
About this study
Official title: Phase 3 Open Label Randomised Multicentre Controlled Trial of Rituxmab and Mycophenolate Mofetil Without Oral Steroids for the Treatment of Lupus Nephritis
The treatment of the multisystem autoimmune disease systemic lupus erythematosus (SLE) remains a challenge, particularly when there is renal involvement (lupus nephritis). For the last 60 years corticosteroids have been the backbone of the treatment of lupus nephritis but they are associated with significant toxicity.
Although randomized placebo controlled trials of Rituximab in non-renal lupus and lupus nephritis did not meet their primary end-points, there is accumulating data that suggests that B cell depletion with Rituximab may be efficacious in lupus disease refractory to conventional therapy. Furthermore, our pilot data suggests that the addition of Rituximab to mycophenolate mofetil (MMF) without oral steroids is at least as effective at inducing a renal response as the standard of care therapy comprising MMF and high dose oral corticosteroids.
RITUXILUP is a proof of concept, open labeled, randomized, controlled, multicentre trial that aims to demonstrate whether the addition of Rituximab to MMF therapy is useful in treating a new flare of lupus nephritis and whether it has a long lasting steroid-sparing, beneficial effect with equal efficacy and greater safety than a conventional regimen of MMF and oral prednisolone. If successful, this trial has the potential to dramatically change the management of lupus nephritis.
Read the detailed description
TRIAL SUMMARY
TITLE RITUXILUP - An open label randomised multicentre controlled trial of RITUXImab and mycophenolate mofetil (MMF) without oral steroids for the treatment of LUPus nephritis
OBJECTIVES
- Is the combination of Rituximab, Methyl prednisolone and MMF as effective in treating lupus nephritis as Methyl prednisolone, oral steroids and MMF?
- Does the omission of oral steroids increase the safety of the treatment regimen?
DESIGN This is a 1:1 randomised, international open label, controlled phase III multicentre trial
SAMPLE SIZE A total of 252 patients: 126 patients in each arm (As of April 2017 decided 25 patients will be maximum recruited following decision to close the study early)
ELIGIBILITY Children (12 years and above) and adults with lupus nephritis ISN/RPS Class III A or A/C, Class IV-G A or A/C, Class IV-S A or A/C, and/or Class V with a urine protein/creatinine ratio (PCR) ≥ 100mg/mmol.
TREATMENT
- Experimental group - Rituximab, IV methyl prednisolone and mycophenolate mofetil
- Control group - oral prednisolone, IV methyl prednisolone and mycophenolate mofetil.
PRIMARY OUTCOME The primary outcome is to demonstrate non-inferiority of the Rituximab arm in comparison to the control arm in the proportion of patients achieving complete renal response (CR) at week 52 without the need for steroid prescription.
SECONDARY OUTCOMES
Safety outcomes:
- Serious Infectious Episodes
- Serious Adverse Events
- Evidence of metabolic abnormalities particularly new onset diabetes
Disease control over time:
- Proportion of patients achieving Partial Response (PR)
- Time to stable CR
- Time to PR
- Proportion of patients in PR who achieve histological remission in those who have a repeat biopsy as part of local standard of care
- Proportion of patients with renal or extra flare
- Cumulative steroid exposure
- Deviation from the steroid taper in the steroid arm and/or introduction of steroids in the steroid-free arm
- Proportion of patients achieving a response as defined by the SLE Responder Index (SRI) at week 52 and annually thereafter as defined by:
- a >4 point reduction in SELENA-SLEDAI score;
- no new BILAG A organ domain score;
- no more than I new BILAG B score;
- no worsening in physician's global assessment (PGA) by >10%;
- must not have received non-protocol treatment.
- Proportion of patients achieving a response as defined by the BILAG-based Composite Lupus Assessment (BICLA) at week 52 and annually thereafter as defined by: BILAG-2004 improvement (BILAG A to B/C/D, BILAG B to C/D and no BILAG worsening, no deterioration in SLEDAI total score, no worsening in physician's global assessment (PGA) by >10% and must not have received non-protocol treatment.
- Being tested
- Oral prednisolone, Rituximab, Mycophenolate mofetil, Methyl prednisolone
- Keywords
- Systemic lupus erythematosus, Lupus, Nephritis
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis, Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral prednisoloneDrug
RituximabDrug
Also called MabThera
Also called Cellcept, Myfenax
Methyl prednisoloneDrug
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | Rituximab, methyl prednisolone and mycophenolate mofetil Receives: Drug: Rituximab; Drug: Mycophenolate mofetil; Drug: Methyl prednisolone |
| Oral prednisolone | Active comparator | Oral prednisolone, methyl prednisolone and mycophenolate mofetil Receives: Drug: Oral prednisolone; Drug: Mycophenolate mofetil; Drug: Methyl prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete renal response (CR) at week 52 without the need to prescribe oral steroids within 1 year
The proportion of participants who achieve a complete renal response at week 52 without the need to prescribe oral steroids within 1 year, except for one course of maximum 30mg for a maximum of 14 days OR one intramuscular or intra-articular injection of steroids
Measured: 1 year
Secondary outcomes (13)
Serious Infectious Episodes, Serious Adverse Events and Adverse events
- Metabolic abnormalities related to steroid exposure: 5. Cumulative steroid exposure over 1 and 2 years 6. Introduction of oral steroids in the B cell depleted patients 7. Patients requiring >10mg oral prednisolone at 1 year and 2 year
Measured: 2 years
Metabolic abnormalities related to steroid exposure
Measured: 2 years
Cumulative steroid exposure over 1 and 2 years
Measured: 2 years
Introduction of oral steroids in the B cell depleted patients
Measured: 2 years
Patients requiring >10mg oral prednisolone at 1 year and 2 year
Measured: 2 years
Proportion of patients achieving CR at 6, 18 and 24 months
Measured: 2 years
Proportion of patients achieving PR at 6,12,8 and 24 months
PR is defined as:
- eGFR at baseline or <20% decrease, ii) AND if not nephrotic at baseline (PCR<300mg/mmol), 50% improvement in urine PCR iii) OR if nephrotic at baseline (PCR >300mg/mmol), 50% improvement in urine PCR AND PCR <300mg/mmol
Measured: 2 years
Mean time to stable CR and mean time to PR
Measured: 2 years
Proportion of patients in PR who achieve histological remission as judged by absence of proliferative lesions and no new subendothelial or subepithelial deposits
Measured: 2 years
Proportion of patients with only 1 or fewer BILAG 2004 Bs in any non-renal organ system at 1 year
Measured: 2 years
Proportion of patients with renal flare
Flare is identified by:
- Proteinuria >50% increase ii) AND above 100mg/mmol for 2 visits iii) and / or in those with normal renal function and normal urinary sediment, a fall of >20% in eGFR on 2 occasions Where possible flare should be proven by repeat renal biopsy.
Measured: 2 years
Mean time to renal flare in patients achieving CR and PR
Measured: 2 years
Proportion of patients achieving normal serum C3,C4 and anti-dsDNA antibodies at week 52
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startApr 2015
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Study assessments for patients recruited continuing per protocol so patients receive a minimum of 6 months follow up. No safety concerns have been raised.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus Erythematosus, Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Ohio State University, Dutch Working Party on Systemic Lupus Erythematosus, EULAR Lupus Nephritis Trial Network Study Group
- Responsible party
- Sponsor
- Investigators
- Liz Lightstone, Dr, Study director, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773616
- Sponsor's protocol ID
- CRO2035
- Acronym
- RITUXILUP
- Status last verified
- Jan 2018
- First submitted
- 1 Nov 2012
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
If Rituximab together with MMF is shown to be as good as standard treatment with MMF and oral steroids, it would be the first time in 60 years that patients with lupus nephritis could be spared the burden of long term steroids.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Open Label Randomised Multicentre Controlled Trial of Rituxmab and Mycophenolate Mofetil Without Oral Steroids for the Treatment of Lupus Nephritis
- ClinicalTrials.gov ID
- NCT01773616
- Acronym / sponsor ID
- RITUXILUP / CRO2035
- Keywords
- Systemic lupus erythematosus, Lupus, Nephritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study assessments for patients recruited continuing per protocol so patients receive a minimum of 6 months follow up. No safety concerns have been raised.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Ohio State University, Dutch Working Party on Systemic Lupus Erythematosus, EULAR Lupus Nephritis Trial Network Study Group
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 23 Jan 2013 (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.
The treatment of the multisystem autoimmune disease systemic lupus erythematosus (SLE) remains a challenge, particularly when there is renal involvement (lupus nephritis). For the last 60 years corticosteroids have been the backbone of the treatment of lupus nephritis but they are associated with significant toxicity.
Although randomized placebo controlled trials of Rituximab in non-renal lupus and lupus nephritis did not meet their primary end-points, there is accumulating data that suggests that B cell depletion with Rituximab may be efficacious in lupus disease refractory to conventional therapy. Furthermore, our pilot data suggests that the addition of Rituximab to mycophenolate mofetil (MMF) without oral steroids is at least as effective at inducing a renal response as the standard of care therapy comprising MMF and high dose oral corticosteroids.
RITUXILUP is a proof of concept, open labeled, randomized, controlled, multicentre trial that aims to demonstrate whether the addition of Rituximab to MMF therapy is useful in treating a new flare of lupus nephritis and whether it has a long lasting steroid-sparing, beneficial effect with equal efficacy and greater safety than a conventional regimen of MMF and oral prednisolone. If successful, this trial has the potential to dramatically change the management of lupus nephritis.
Detailed description
TRIAL SUMMARY
TITLE RITUXILUP - An open label randomised multicentre controlled trial of RITUXImab and mycophenolate mofetil (MMF) without oral steroids for the treatment of LUPus nephritis
OBJECTIVES
- Is the combination of Rituximab, Methyl prednisolone and MMF as effective in treating lupus nephritis as Methyl prednisolone, oral steroids and MMF?
- Does the omission of oral steroids increase the safety of the treatment regimen?
DESIGN This is a 1:1 randomised, international open label, controlled phase III multicentre trial
SAMPLE SIZE A total of 252 patients: 126 patients in each arm (As of April 2017 decided 25 patients will be maximum recruited following decision to close the study early)
ELIGIBILITY Children (12 years and above) and adults with lupus nephritis ISN/RPS Class III A or A/C, Class IV-G A or A/C, Class IV-S A or A/C, and/or Class V with a urine protein/creatinine ratio (PCR) ≥ 100mg/mmol.
TREATMENT
- Experimental group - Rituximab, IV methyl prednisolone and mycophenolate mofetil
- Control group - oral prednisolone, IV methyl prednisolone and mycophenolate mofetil.
PRIMARY OUTCOME The primary outcome is to demonstrate non-inferiority of the Rituximab arm in comparison to the control arm in the proportion of patients achieving complete renal response (CR) at week 52 without the need for steroid prescription.
SECONDARY OUTCOMES
Safety outcomes:
- Serious Infectious Episodes
- Serious Adverse Events
- Evidence of metabolic abnormalities particularly new onset diabetes
Disease control over time:
- Proportion of patients achieving Partial Response (PR)
- Time to stable CR
- Time to PR
- Proportion of patients in PR who achieve histological remission in those who have a repeat biopsy as part of local standard of care
- Proportion of patients with renal or extra flare
- Cumulative steroid exposure
- Deviation from the steroid taper in the steroid arm and/or introduction of steroids in the steroid-free arm
- Proportion of patients achieving a response as defined by the SLE Responder Index (SRI) at week 52 and annually thereafter as defined by:
- a >4 point reduction in SELENA-SLEDAI score;
- no new BILAG A organ domain score;
- no more than I new BILAG B score;
- no worsening in physician's global assessment (PGA) by >10%;
- must not have received non-protocol treatment.
- Proportion of patients achieving a response as defined by the BILAG-based Composite Lupus Assessment (BICLA) at week 52 and annually thereafter as defined by: BILAG-2004 improvement (BILAG A to B/C/D, BILAG B to C/D and no BILAG worsening, no deterioration in SLEDAI total score, no worsening in physician's global assessment (PGA) by >10% and must not have received non-protocol treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: Rituximab, Drug: Mycophenolate mofetil, Drug: Methyl prednisoloneRituximab, methyl prednisolone and mycophenolate mofetil |
| Oral prednisolone | Active comparator | Drug: Oral prednisolone, Drug: Mycophenolate mofetil, Drug: Methyl prednisoloneOral prednisolone, methyl prednisolone and mycophenolate mofetil |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (19 listed)
- Obsolescence of >50% of the glomeruli or tubulointerstitial scarring of >50% or cellular crescents in >50% of the glomeruli
- Severe "critical" SLE flare defined as:
- Pregnant or lactating. Woman who have child bearing potential must have two negative pregnancy test results with a sensitivity of ≥ 25 mIU/mL: one from a serum pregnancy test at day -8 to day -10 of screening and another from a urine pregnancy test at day 1 prior to randomisation. If the timeline is shortened because of clinical urgency, then there must be a negative serum pregnancy test with a sensitivity of ≥ 25 mIU/mL within 1-2 days before study start
- Patients not willing for their GP to be informed of their participation in this study
- Patients should not be on or require maintenance steroids and should not have had more than 12 weeks of steroids in the period immediately preceding recruitment irrespective of dose
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 |
|---|---|---|
| Oral prednisolone | Drug | Oral prednisolone |
| RituximabAlso: MabThera | Drug | Rituximab |
| Mycophenolate mofetilAlso: Cellcept, Myfenax | Drug | Oral prednisolone, Rituximab |
| Methyl prednisolone | Drug | Oral prednisolone, Rituximab |
Primary outcome
Complete renal response (CR) at week 52 without the need to prescribe oral steroids within 1 year
Time frame: 1 year
The proportion of participants who achieve a complete renal response at week 52 without the need to prescribe oral steroids within 1 year, except for one course of maximum 30mg for a maximum of 14 days OR one intramuscular or intra-articular injection of steroids
13 secondary outcomes
Serious Infectious Episodes, Serious Adverse Events and Adverse events
Time frame: 2 years
Metabolic abnormalities related to steroid exposure
Time frame: 2 years
Cumulative steroid exposure over 1 and 2 years
Time frame: 2 years
Introduction of oral steroids in the B cell depleted patients
Time frame: 2 years
Patients requiring >10mg oral prednisolone at 1 year and 2 year
Time frame: 2 years
Proportion of patients achieving CR at 6, 18 and 24 months
Time frame: 2 years
Proportion of patients achieving PR at 6,12,8 and 24 months
Time frame: 2 years
Mean time to stable CR and mean time to PR
Time frame: 2 years
Proportion of patients in PR who achieve histological remission as judged by absence of proliferative lesions and no new subendothelial or subepithelial deposits
Time frame: 2 years
Proportion of patients with only 1 or fewer BILAG 2004 Bs in any non-renal organ system at 1 year
Time frame: 2 years
Proportion of patients with renal flare
Time frame: 2 years
Mean time to renal flare in patients achieving CR and PR
Time frame: 2 years
Proportion of patients achieving normal serum C3,C4 and anti-dsDNA antibodies at week 52
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Study assessments for patients recruited continuing per protocol so patients receive a minimum of 6 months follow up. No safety concerns have been raised.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- BackgroundIf Rituximab together with MMF is shown to be as good as standard treatment with MMF and oral steroids, it would be the first time in 60 years that patients with lupus nephritis could be spared the burden of long term steroids.
- Related InfoLink provided by the sponsor.
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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.
Liz Lightstone, Dr study director
Imperial College London
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral prednisolone, Rituximab and Mycophenolate mofetil in people with Systemic Lupus Erythematosus, Lupus Nephritis, run by Imperial College London at 11 sites in United Kingdom.
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 0 inclusion and 19 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: stopped early, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom. 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?
The study was stopped early (reason given: Study assessments for patients recruited continuing per protocol so patients receive a minimum of 6 months follow up. No safety concerns have been raised.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete renal response (CR) at week 52 without the need to prescribe oral steroids within 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01773616, which also lists 1 linked publication.
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 1 Feb 2018.