Lupus NephritisPhase 2/3NCT04892212
Sirolimus in Treatment of Proteinuric Flares of Lupus Nephritis
A Phase 2/3 study testing Sirolimus in people with Lupus Nephritis and Immunosuppression, run by Peking Union Medical College Hospital.
Trial summary
This a single-centre, one-arm, open-label pilot study. Eligible patients with mild proteinuric flares of lupus nephritis Class III/IV±V are received sirolimus without changing previous immunosuppressive medication during 12-week follow-up. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lupus Nephritis, Immunosuppression, Effect of Drug
- What is being tested?
- Sirolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2021to 30 Oct 2023
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Biopsy-proven Class III or IV±V lupus nephritis (ISN/RPS 2003 lupus nephritis classification) with biopsy performed within 48 weeks before inclusion.
- Males or females aged 18 to 60 years old at the time of screening.
- The mild proteinuric flare of lupus nephritis is defined as meeting all of the following criteria :
- Persistently increased proteinuria after complete remission, and 24-hr proteinuria≥1.0g/day or doubling of proteinuria after partial remission, and 24-hr proteinuria≥2.0g/day
- No hypoalbuminemia: serum albumin ≥35g/L
- Stable renal function: serum creatinine<25% increase above the level at the time of renal disease remission
- Eligible to sign informed-consent independently
Who cannot join
- Renal disease unrelated to SLE (e.g. diabetes mellitus, other glomerular or tubulointerstitial diseases, renovascular disease), or transplanted kidney
- Estimate glomerular filtration rate (eGFR by CKD-EPI)<45mL/min per 1.73m^2 at the time of screening
- Renal biopsy showing cellular of fibrocellular crescent in more than 25% of glomeruli
- Central nervous system (CNS) or other severe organ manifestations of lupus that necessitate aggressive immunosuppressive therapy on its own.
- Co-morbidities that require corticosteroid therapy (e.g. asthma, inflammatory bowel disease)
- Any increased dose of corticosteroids or other immunosuppressive medication including cyclophosphamide, mycophenolate, leflunomide, calcineurin inhibitors, azathioprine, methotrexate, or use of biological agents regardless of duration, with the past six months
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- Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection history: seropositivity of HBV surface antigen (HBsAg) or HCV antibodies (HCV-Ab)
- Women who are pregnant or breastfeeding
- Women with childbearing potential or their male partners, who refuse to use an effective birth control method
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Pilot Study of Sirolimus in Treatment of Proteinuric Flares of Lupus Nephritis
This a single-centre, one-arm, open-label pilot study. Eligible patients with mild proteinuric flares of lupus nephritis Class III/IV±V are received sirolimus without changing previous immunosuppressive medication during 12-week follow-up.
Primary Objective:
- To investigate the efficacy of sirolimus for mild proteinuric flares in patients with Class III/IV±V lupus nephritis
Secondary Objective:
- To assess the safety and tolerability of sirolimus treatment for mild proteinuric flares in patients with Class III/IV±V lupus nephritis
Read the detailed description
Lupus nephritis is a common and serious complication of systemic lupus erythematosus (SLE). It often requires aggressive immunosuppressive therapy. Although majority of patients with severe lupus nephritis achieve a complete or partial remission after 6-month induction treatment, renal flares can still occur during maintenance therapy. Whether patients with mild proteinuric flares should receive intensive immunosuppressive therapy is unclear. In pathogenesis of SLE, T-cell dysfunction is attributed to the activation of the mammalian target of rapamycin (mTOR). Previous prospective and retrospective studies in SLE or lupus nephritis showed the effect of mTOR blockade on systemic disease activity index or severe lupus nephritis as initial or maintenance therapy.
Eligible subjects with biopsy-proven Class III/IV±V lupus nephritis(ISN/RPS 2003) are received oral sirolimus without change previous immunosuppressive therapy. We follow up the included patients at Week 2, Week 4, Week6, Week 8 and Week 12 regularly.
The investigator will actively detect and inquire about the occurrence of adverse events (AEs)/ severe adverse events (SAEs) at every visit/ contact during the study. The clinical trials insurance is prepaid by sponsor to cover the design risks of the protocol and liability/ compensation to the research subject for bodily injury or death resulting from their participation in the trial.
- Conditions
- Lupus Nephritis, Immunosuppression, Effect of Drug
- Being tested
- Sirolimus
- Keywords
- Sirolimus, Lupus Nephritis, Renal Flare
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Also called Rapamycin
The daily dose of sirolimus is divided twice.
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus group | Experimental | 1. The initial dose of sirolimus is 1mg/day. And the serum trough level of sirolimus is monitored at Week 2, Week 4, Week 8, and Week 12，respectively. The target serum trough level of sirolimus is 5-8 ng/mL. The dose of sirolimus is titrated according to therapeutic drug level monitoring.
2. The previous immunosuppressive medication is not allowed to be changed during the 3-month follow-up, unless premature discontinuation from study. Receives: Drug: Sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients achieving sustained Renal Response(RR)
Sustained RR is defined as satisfying all of the following criteria:
1)Proteinuria is improved by ≥50% compared with baseline
2)24-hr urine protein < 1g
3)Serum creatinine is not higher than 15% above baseline level
4)No occurrence of non-renal disease flare after achieving response to treatment.
Measured: at the end of 12 weeks (3 months) from baseline
Secondary outcomes (14)
Complete renal remission
- 24-hr urine protein<0.3g/day or urine Protein-Creatinine ratio (uPCR)<300mg/g
- Serum creatinine not higher than 15% above baseline level
Measured: at the end of 12 weeks (3 months) from baseline
Partial renal remission
- 24-hr urine protein<3.5g/day or uPCR<3500mg/g
- Serum creatinine not higher than 15% above baseline level
Measured: at the end of 12 weeks (3 months) from baseline
Rate of non-renal flare
Central nervous system or other severe organ manifestations of SLE that necessitate aggressive immunosuppressive therapy on its own
Measured: during the 3-month follow up
Safety and tolerability of study medications
The following parameters will be monitored:
- Increase of serum creatinine level>15% from baseline and whether it is reversible or irreversible
- Episodes with sirolimus level above the target range
- New-onset hypertension or worsening hypertensive control that required increase of antihypertensive medication
- Infectious requiring hospitalization and the causative agents
- Hospitalization episodes- cause, duration (days)
- Hypokalemia: serum potassium <3.5mmol/L
- Metabolic acidosis with HCO3 <17mmol/L
- New-onset hypercholesterolemia present at 3 months or beyond from baseline and/or addition of lipid-lowering drug(s).
- Premature discontinuation from the study due to treating intolerance
- Premature discontinuation from the study due to rapid disease progression or other reasons
- Failure to adhere to the protocol defined corticosteroid reduction regimen
- Other adverse clinical events or events considered clinically significant
Measured: during the 3-month follow up
Increase of serum creatinine level>15% from baseline
Increase of serum creatinine level (μmol/L)>15% from baseline and whether it is reversible or irreversible.
Measured: during the 3-month follow up
Episodes with sirolimus level above the target range
Episodes with sirolimus level above the target range（serum sirolimus trough level>8ng/mL) will be recorded.
Measured: during the 3-month follow up
New-onset hypertension or worsening hypertensive control that required increase of antihypertensive medication
Hypertension be diagnosed when a person's systolic blood pressure (SBP) in the office or clinic is ≥140 mm Hg and/or their diastolic blood pressure (DBP) is ≥90 mm Hg following repeated examination.
New-onset hypertension or worsening hypertensive control that required increase of antihypertensive medication will be recorded.
Measured: during the 3-month follow up
Infection requiring hospitalization
Infection requiring hospitalization will be recorded including the site of infection, the causative agent and duration (days).
Measured: during the 3-month follow up
Hypokalemia
Serum potassium <3.5mmol/L
Measured: during the 3-month follow up
Hypercholesterolemia
New-onset hypercholesterolemia present during follow-up or beyond from baseline and/or addition of lipid-lowering drug(s)
Measured: during the 3-month follow up
Premature discontinuation from the study
The time of of discontinuation from study will be recorded, and the discontinuation is due to:
- treating intolerance
- rapid disease progression
- other reasons
Measured: during the 3-month follow up
Failure to adhere to the protocol
Failure to adhere to the protocol including:
- do not titer the dose of sirolimus following study protocol
- increase the dose of other immunosuppressives personally without the permission of physician
Measured: during the 3-month follow up
Changes in Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)
Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) assesses disease activity by scoring 24 weighted disease activity descriptors of SLE as "present" or "absent" in preceding 10 days. A patient's total score is the sum of all marked SLE-related descriptors; a total score ranges between 0 and 105, with a higher score representing a more significant degree of disease activity.
Assessment scales of SELENA-SLEDAI is available online.
Measured: from baseline to end of 12 weeks
Changes in Physician Global Assessement (PGA)
The Physician Global Assessment (PGA) is a visual analog scale (VAS) using 3 benchmarks for assessing disease activity over the last 2 weeks. Mild flare will score 1.0 point, moderate flares will score a 2.0-2.5 point and severe flares will score a 3 on the 0-3 analog scale. PGA is available online.
Measured: from baseline to end of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start30 Jun 2021 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- North China Pharmaceutical Group Corporation
- Responsible party
- Sponsor
- Investigators
- Xue-mei Li, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892212
- Sponsor's protocol ID
- HS-2743
- Status last verified
- May 2021
- First submitted
- 10 May 2021
- Last updated
- 19 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yap DYH, Tang C, Chan GCW, Kwan LPY, Ma MKM, Mok MMY, Chan TM. Longterm Data on Sirolimus Treatment in Patients with Lupus Nephritis. J Rheumatol. 2018 Dec;45(12):1663-1670. doi: 10.3899/jrheum.180507. Epub 2018 Oct 1.
PubMed 30275264Lai ZW, Kelly R, Winans T, Marchena I, Shadakshari A, Yu J, Dawood M, Garcia R, Tily H, Francis L, Faraone SV, Phillips PE, Perl A. Sirolimus in patients with clinically active systemic lupus erythematosus resistant to, or intolerant of, conventional medications: a single-arm, open-label, phase 1/2 trial. Lancet. 2018 Mar 24;391(10126):1186-1196. doi: 10.1016/S0140-6736(18)30485-9. Epub 2018 Mar 15.
PubMed 29551338Eriksson P, Wallin P, Sjowall C. Clinical Experience of Sirolimus Regarding Efficacy and Safety in Systemic Lupus Erythematosus. Front Pharmacol. 2019 Feb 6;10:82. doi: 10.3389/fphar.2019.00082. eCollection 2019.
PubMed 30787878Esatoglu SN, Seyahi E. Is sirolimus a treatment option for patients with systemic lupus erythematosus? Clin Exp Rheumatol. 2019 Nov-Dec;37 Suppl 122(6):13. Epub 2019 Jul 12. No abstract available.
PubMed 31376256Ma MKM, Yung S, Chan TM. mTOR Inhibition and Kidney Diseases. Transplantation. 2018 Feb;102(2S Suppl 1):S32-S40. doi: 10.1097/TP.0000000000001729.
PubMed 29369972
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Sirolimus in Treatment of Proteinuric Flares of Lupus Nephritis
- ClinicalTrials.gov ID
- NCT04892212
- Acronym / sponsor ID
- HS-2743
- Conditions
- Lupus Nephritis, Immunosuppression, Effect of Drug
- Keywords
- Sirolimus, Lupus Nephritis, Renal Flare
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- North China Pharmaceutical Group Corporation
- Study start
- 30 Jun 2021 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 19 May 2021 (actual)
- 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.
This a single-centre, one-arm, open-label pilot study. Eligible patients with mild proteinuric flares of lupus nephritis Class III/IV±V are received sirolimus without changing previous immunosuppressive medication during 12-week follow-up.
Primary Objective:
- To investigate the efficacy of sirolimus for mild proteinuric flares in patients with Class III/IV±V lupus nephritis
Secondary Objective:
- To assess the safety and tolerability of sirolimus treatment for mild proteinuric flares in patients with Class III/IV±V lupus nephritis
Detailed description
Lupus nephritis is a common and serious complication of systemic lupus erythematosus (SLE). It often requires aggressive immunosuppressive therapy. Although majority of patients with severe lupus nephritis achieve a complete or partial remission after 6-month induction treatment, renal flares can still occur during maintenance therapy. Whether patients with mild proteinuric flares should receive intensive immunosuppressive therapy is unclear. In pathogenesis of SLE, T-cell dysfunction is attributed to the activation of the mammalian target of rapamycin (mTOR). Previous prospective and retrospective studies in SLE or lupus nephritis showed the effect of mTOR blockade on systemic disease activity index or severe lupus nephritis as initial or maintenance therapy.
Eligible subjects with biopsy-proven Class III/IV±V lupus nephritis(ISN/RPS 2003) are received oral sirolimus without change previous immunosuppressive therapy. We follow up the included patients at Week 2, Week 4, Week6, Week 8 and Week 12 regularly.
The investigator will actively detect and inquire about the occurrence of adverse events (AEs)/ severe adverse events (SAEs) at every visit/ contact during the study. The clinical trials insurance is prepaid by sponsor to cover the design risks of the protocol and liability/ compensation to the research subject for bodily injury or death resulting from their participation in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sirolimus group | Experimental | Drug: Sirolimus1. The initial dose of sirolimus is 1mg/day. And the serum trough level of sirolimus is monitored at Week 2, Week 4, Week 8, and Week 12，respectively. The target serum trough level of sirolimus is 5-8 ng/mL. The dose of sirolimus is titrated according to therapeutic drug level monitoring. 2. The previous immunosuppressive medication is not allowed to be changed during the 3-month follow-up, unless premature discontinuation from study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Biopsy-proven Class III or IV±V lupus nephritis (ISN/RPS 2003 lupus nephritis classification) with biopsy performed within 48 weeks before inclusion.
- Males or females aged 18 to 60 years old at the time of screening.
- The mild proteinuric flare of lupus nephritis is defined as meeting all of the following criteria :
- Eligible to sign informed-consent independently
Key exclusion criteria (9 listed)
- Renal disease unrelated to SLE (e.g. diabetes mellitus, other glomerular or tubulointerstitial diseases, renovascular disease), or transplanted kidney
- Estimate glomerular filtration rate (eGFR by CKD-EPI)<45mL/min per 1.73m^2 at the time of screening
- Renal biopsy showing cellular of fibrocellular crescent in more than 25% of glomeruli
- Central nervous system (CNS) or other severe organ manifestations of lupus that necessitate aggressive immunosuppressive therapy on its own.
- Co-morbidities that require corticosteroid therapy (e.g. asthma, inflammatory bowel disease)
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 |
|---|---|---|
| SirolimusAlso: RapamycinThe daily dose of sirolimus is divided twice. | Drug | Sirolimus group |
Primary outcome
The number of patients achieving sustained Renal Response(RR)
Time frame: at the end of 12 weeks (3 months) from baseline
Sustained RR is defined as satisfying all of the following criteria: 1)Proteinuria is improved by ≥50% compared with baseline 2)24-hr urine protein < 1g 3)Serum creatinine is not higher than 15% above baseline level 4)No occurrence of non-renal disease flare after achieving response to treatment.
14 secondary outcomes
Complete renal remission
Time frame: at the end of 12 weeks (3 months) from baseline
Partial renal remission
Time frame: at the end of 12 weeks (3 months) from baseline
Rate of non-renal flare
Time frame: during the 3-month follow up
Safety and tolerability of study medications
Time frame: during the 3-month follow up
Increase of serum creatinine level>15% from baseline
Time frame: during the 3-month follow up
Episodes with sirolimus level above the target range
Time frame: during the 3-month follow up
New-onset hypertension or worsening hypertensive control that required increase of antihypertensive medication
Time frame: during the 3-month follow up
Infection requiring hospitalization
Time frame: during the 3-month follow up
Hypokalemia
Time frame: during the 3-month follow up
Hypercholesterolemia
Time frame: during the 3-month follow up
Premature discontinuation from the study
Time frame: during the 3-month follow up
Failure to adhere to the protocol
Time frame: during the 3-month follow up
Changes in Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)
Time frame: from baseline to end of 12 weeks
Changes in Physician Global Assessement (PGA)
Time frame: from baseline to end of 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Background: PubMed 30275264Yap DYH, Tang C, Chan GCW, Kwan LPY, Ma MKM, Mok MMY, Chan TM. Longterm Data on Sirolimus Treatment in Patients with Lupus Nephritis. J Rheumatol. 2018 Dec;45(12):1663-1670. doi: 10.3899/jrheum.180507. Epub 2018 Oct 1.
- Background: PubMed 29551338Lai ZW, Kelly R, Winans T, Marchena I, Shadakshari A, Yu J, Dawood M, Garcia R, Tily H, Francis L, Faraone SV, Phillips PE, Perl A. Sirolimus in patients with clinically active systemic lupus erythematosus resistant to, or intolerant of, conventional medications: a single-arm, open-label, phase 1/2 trial. Lancet. 2018 Mar 24;391(10126):1186-1196. doi: 10.1016/S0140-6736(18)30485-9. Epub 2018 Mar 15.
- Background: PubMed 30787878Eriksson P, Wallin P, Sjowall C. Clinical Experience of Sirolimus Regarding Efficacy and Safety in Systemic Lupus Erythematosus. Front Pharmacol. 2019 Feb 6;10:82. doi: 10.3389/fphar.2019.00082. eCollection 2019.
- Background: PubMed 31376256Esatoglu SN, Seyahi E. Is sirolimus a treatment option for patients with systemic lupus erythematosus? Clin Exp Rheumatol. 2019 Nov-Dec;37 Suppl 122(6):13. Epub 2019 Jul 12. No abstract available.
- Background: PubMed 29369972Ma MKM, Yung S, Chan TM. mTOR Inhibition and Kidney Diseases. Transplantation. 2018 Feb;102(2S Suppl 1):S32-S40. doi: 10.1097/TP.0000000000001729.
- Individual participant dataSharing planned: No
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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.
Xue-mei Li, MD principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sirolimus in people with Lupus Nephritis and Immunosuppression, run by Peking Union Medical College Hospital.
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 7 inclusion and 9 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 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Chao Li, MD (86-010-69155058, superchad099@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients achieving sustained Renal Response(RR) (time frame: at the end of 12 weeks (3 months) from baseline). 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 NCT04892212, which also lists 5 linked publications.
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 19 May 2021.