Lupus NephritisPhase 3RITULUPNCT01765842
Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy
A Phase 3 study testing Rituximab in people with Lupus Nephritis, run by Fundación Pública Andaluza Progreso y Salud at 3 sites in Spain.
Trial summary
Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy Resistant to Conventional Treatments Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesSpain
- Study dates
- Nov 2012to Dec 2015
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both men and women between 18 and 70 years.
- Patient with active lupus nephritis, previously treated with cyclophosphamide and mycophenolate (sodium or mofetil), who have not received rituximab in the previous year.
- Women in childbearing age must have a pregnancy test in serum or urine negative and should use a contraceptive method suitable since at least 14 days prior to their inclusion in the study and up to 6 months after the last dose of the medication of the test.
- Informed consent form signed.
Who cannot join
- Patients treated with rituximab in the previous years
- Active/sepsis serious infections
- Renal biopsy showing interstitial fibrosis and/or glomerular over 75%.
- Known neoplasia
- Heart failure with III/IV functional class
- Pregnancy
Show all 15Show fewer
- Nursing
- Known anaphylaxis to the product
- History of hepatitis c
- History of tuberculosis
- Cardiovascular disease or uncontrolled hypertension
- Chronic hepatitis B
- Serious Cytopenia (granulocytes < 500/mm3, further < 10000/mm3)
- Immunodeficiency (CVI, immunoglobulins deficiency)
- Infection with HIV
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
San Cecilio Hospital
Granada, Granada, 18012
Carlos Haya Hospital
Málaga, Málaga, 29010
Virgen del Rocío, Hospital
Seville, Seville, 41013
About this study
Official title: Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy Resistant to Conventional Treatments.
Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy Resistant to Conventional Treatments
Read the detailed description
Randomized, open, controlled, multicenter, clinical trial in patients with lupus nephritis previously treated with cyclophosphamide and mycophenolate. These patient can not have received Rituximab in the previous year. The number of patients estimated to reach statistical significance is 18 in each arm, a total sample size of 32 patients is needed.
The hypothesis is that the alternative procedure (a second cycle of Rituximab)will reduce the relapse rate of lupus nephritis and the consequent deterioration of renal function. Besides it will reduce health care expenses(hospitalization, medication, hemodialysis and renal transplantation).
- Conditions
- Lupus Nephritis
- Being tested
- Rituximab
- Keywords
- Lupus Nephritis, remission, immunosuppressive treatment
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabBiological
Also called Mabthera
Only one cycle of rituximab will be administered in this arm.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab (1 cycle) | Active comparator | 1 cycle of Rituximab (4 i.v. infusions):
Day 0: 375 mg/m2 Day 7: 375 mg/m2 Day 14: 375 mg/m2 Day 21: 375 mg/m2 Receives: Biological: Rituximab |
| Rituximab (2 cycles) | Experimental | A second cycle of Rituximab
First cycle of Rituximab (4 i.v. infusions):
Day 0: 375 mg/m2 Day 7: 375 mg/m2 Day 14: 375 mg/m2 Day 21: 375 mg/m2
Second cycle of Rituximab (4 i.v. infusions, 6 months later) Receives: Biological: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete or partial response in lupus nephritis
Complete response defined as:
- Glomerular Filtration Rate (GFR)≥ 60, 73 m2 (or decline to baseline or ± 15% of baseline in those with GFR <60 ml/min/1, 73m2).
- Proteinuria ≤ 0.5 g/24 hours.
- Inactive urine sediment (red cells, white cells, red cell casts according to local laboratory ranges).
- Serum albumin> 3 g / dl
Partial response defined as:
In patients with proteinuria ≥ 3.5 gr/24 h , decreased proteinuria <3.5 gr/24 hours.
- In patients with baseline proteinuria <3.5 gr/24 hours, reduced proteinuria> 50% of baseline.
- In both situations, stabilization (± 25%) or reduce of the Glomerular Filtration Rate.
Measured: Assessment at 12 months
Secondary outcomes (4)
Renal function
Proportion of patients achieving a stabilization of renal function (Glomerular filtration rate of ± 25% over baseline or serum creatinine within normal range)
Measured: 24 months of follow-up
Safety
Incidence of adverse events, serious adverse events and adverse events that led to the interruption of the study.
Measured: 24 months of follow-up
Rescue medication
Need for immunosuppressive treatment added to the experimental pattern:
- - Mycophenolate
- - Azathioprine
- - Methotrexate
Measured: 24 months of follow-up
Efficacy
Improvements in Selena-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) score results
Measured: 24 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2014
- Study completionDec 2015 (estimated)
Why it stopped: The recruitment period has finished without reaching sample size
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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Spain
- Responsible party
- Sponsor
- Investigators
- María Jesús Castillo Palma, PhD, Study chair, Virgen del Rocío Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765842
- Sponsor's protocol ID
- RITULUP
- Acronym
- RITULUP
- Status last verified
- Jan 2013
- First submitted
- 3 Jan 2013
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy Resistant to Conventional Treatments.
- ClinicalTrials.gov ID
- NCT01765842
- Acronym / sponsor ID
- RITULUP / RITULUP
- Conditions
- Lupus Nephritis
- Keywords
- Lupus Nephritis, remission, immunosuppressive treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The recruitment period has finished without reaching sample size
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Collaborators
- Ministry of Health, Spain
- Study start
- Nov 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 10 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.
Comparison of the Efficacy of Two Rituximab Treatment Regimens in Patients With Lupus Nephropathy Resistant to Conventional Treatments
Detailed description
Randomized, open, controlled, multicenter, clinical trial in patients with lupus nephritis previously treated with cyclophosphamide and mycophenolate. These patient can not have received Rituximab in the previous year. The number of patients estimated to reach statistical significance is 18 in each arm, a total sample size of 32 patients is needed.
The hypothesis is that the alternative procedure (a second cycle of Rituximab)will reduce the relapse rate of lupus nephritis and the consequent deterioration of renal function. Besides it will reduce health care expenses(hospitalization, medication, hemodialysis and renal transplantation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab (1 cycle) | Active comparator | Biological: Rituximab1 cycle of Rituximab (4 i.v. infusions): Day 0: 375 mg/m2 Day 7: 375 mg/m2 Day 14: 375 mg/m2 Day 21: 375 mg/m2 |
| Rituximab (2 cycles) | Experimental | Biological: RituximabA second cycle of Rituximab First cycle of Rituximab (4 i.v. infusions): Day 0: 375 mg/m2 Day 7: 375 mg/m2 Day 14: 375 mg/m2 Day 21: 375 mg/m2 Second cycle of Rituximab (4 i.v. infusions, 6 months later) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both men and women between 18 and 70 years.
- Patient with active lupus nephritis, previously treated with cyclophosphamide and mycophenolate (sodium or mofetil), who have not received rituximab in the previous year.
- Women in childbearing age must have a pregnancy test in serum or urine negative and should use a contraceptive method suitable since at least 14 days prior to their inclusion in the study and up to 6 months after the last dose of the medication of the test.
- Informed consent form signed.
Key exclusion criteria (15 listed)
- Patients treated with rituximab in the previous years
- Active/sepsis serious infections
- Renal biopsy showing interstitial fibrosis and/or glomerular over 75%.
- Known neoplasia
- Heart failure with III/IV functional class
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 |
|---|---|---|
| RituximabAlso: MabtheraOnly one cycle of rituximab will be administered in this arm. | Biological | Rituximab (1 cycle), Rituximab (2 cycles) |
Primary outcome
Rate of complete or partial response in lupus nephritis
Time frame: Assessment at 12 months
Complete response defined as: * Glomerular Filtration Rate (GFR)≥ 60, 73 m2 (or decline to baseline or ± 15% of baseline in those with GFR <60 ml/min/1, 73m2). * Proteinuria ≤ 0.5 g/24 hours. * Inactive urine sediment (red cells, white cells, red cell casts according to local laboratory ranges). * Serum albumin> 3 g / dl Partial response defined as: In patients with proteinuria ≥ 3.5 gr/24 h , decreased proteinuria <3.5 gr/24 hours. * In patients with baseline proteinuria <3.5 gr/24 hours, reduced proteinuria> 50% of baseline. * In both situations, stabilization (± 25%) or reduce of the Glomerular Filtration Rate.
4 secondary outcomes
Renal function
Time frame: 24 months of follow-up
Safety
Time frame: 24 months of follow-up
Rescue medication
Time frame: 24 months of follow-up
Efficacy
Time frame: 24 months of follow-up
Results and safety
The study was stopped early (reason given: The recruitment period has finished without reaching sample size). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 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.
María Jesús Castillo Palma, PhD study chair
Virgen del Rocío Hospital
3 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 Rituximab in people with Lupus Nephritis, run by Fundación Pública Andaluza Progreso y Salud at 3 sites in Spain.
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 4 inclusion and 15 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 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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: The recruitment period has finished without reaching sample size). 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?
Rate of complete or partial response in lupus nephritis (time frame: Assessment at 12 months). 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 10 Jul 2015.