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Systemic Lupus ErythematosusPhase 4NCT05916781

Effectiveness of Mycophenolate Mofetil Combined With Tacrolimus for Steroid Tapering in Systemic Lupus Erythematosus

A Phase 4 study testing Mycophenolate Mofetil, Tacrolimus and Glucocorticoid in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by Chinese SLE Treatment And Research Group at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to determine whether mycophenolate mofetil(MMF) combined with tacrolimus(TAC) can maintain remission in patients with lupus nephritis (LN) who have reached treatment targets after steroid tapering. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Systemic Lupus Erythematosus, Lupus Nephritis
What is being tested?
Mycophenolate Mofetil, Tacrolimus and Glucocorticoid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
1 siteChina
Study dates
1 Jul 2023to 31 Jul 2026
Phase
Phase 4
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Systemic lupus erythematosus participants diagnosed with 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria, fulfilled with American College of Rheumatology (ACR) lupus nephritis definition, and have reached treatment target (accord with lupus nephritis clinical remission and DORIS) for at least 6 months. The target is defined as: (1)24h urine protein ≤0.5g/d；(2)stable of improved renal function (baseline creatinine ±10% or decrease 15%)；(3)clinical SLE Disease Activity Index (cSLEDAI) =0 (all scores are required zero, except hypocomplementemia and anti-dsDNA antibody positivity)；(4)PGA score (Physician Global Assessment)<0.5; (5)prednisone or equivalent steroid dose≤5mg/d；(6)stable use of immunosuppressants and antimalarial drugs; (7)no use of biological agents.
  • According to the physician, the participant can accept this treatment.
  • The participant is willing to join this clinical trial, has good compliance, and could understand and sign the informed consent before the study begins.

Who cannot join

  • SLE complicated with important organ dysfunction, including consciousness disorder, cognitive disorder, renal dysfunction, heart dysfunction (NYHA class 3, 4), pulmonary arterial hypertension, and interstitial lung disease.
  • SLE with active vital organ disease (not satisfied with DORIS), including but not limited to active neuropsychiatric systemic lupus erythematosus, lupus nephritis, thrombocytopenia, hemolytic anemia, myocardial involvement, gastrointestinal involvement, etc.
  • Participants who are allergic to or intolerant with mycophenolate mofetil or tacrolimus.
  • Participants with acute and chronic infections requiring anti-infective treatment, including but not limited to tuberculosis infection, Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infection, Human Immunodeficiency Virus (HIV) infection, and Cytomegalovirus (CMV) infection.
  • Participants who are pregnant or planning to become pregnant.
  • Participants who have used biological agents within 6 months before enrollment.
  • The researcher considers any condition that may cause the participant to be unable to complete the study or bring an obvious risk to the participant.

Trial locations and contacts

1 site in 1 country.

Can Huang, MD contact

86-13426191948

huang_can@yeah.net

China1 site, 1 recruiting

  • Peking Union Medical College Hospital

    Beijing, 100730

    Can Huang, MD, 86-13426191948, huang_can@yeah.net

    Recruiting

Other trials in China

About this study

Official title: Effectiveness of Mycophenolate Mofetil Combined With Tacrolimus for Steroid Tapering in Systemic Lupus Erythematosus: A Prospective, Random Control, Open-label, Single Center Clinical Trial

The goal of this clinical trial is to determine whether mycophenolate mofetil(MMF) combined with tacrolimus(TAC) can maintain remission in patients with lupus nephritis (LN) who have reached treatment targets after steroid tapering. The main question[s] it aims to answer are:

  • The efficacy, safety and tolerability of MMF combined with TAC regimen in the treatment of LN patients in the maintenance period.
  • The influence of low-dose steroid on carotid intima thickness (CIMT).
  • The omics and cell-free RNA (cfRNA) spectral differences related to lupus flare.
  • The differences in health economics between steroid tapering and steroid maintenance patients.

Participants will be randomly assigned into 2 groups. In the steroid tapering group, participants will take MMF+TAC treatment without steroid for 1 year, and participants who stop steroid treatment without lupus flare will be randomly assigned to monotherapy with MMF or TAC. In the steroid maintenance group, participants will take MMF+TAC+steroid for 1 year, and participants without lupus flare will stop the use of steroid for 6 months. Participants without lupus flare after the stop of steroid will be randomly assigned to monotherapy with MMF or TAC.

Read the detailed description

According to the references, with the maintenance of steroid, 1-year lupus flare rate is 7%. Investigators plan to take a 2-year follow-up for participants, so the proportion of patients without flare in steroid maintenance group should be 86%. As this is a non-inferiority study, investigators hypothesize that in steroid tapering group, the proportion of patients without flare is also 86%. Investigators set α=0.05 (two-sided), 1-β=0.90, non-inferiority value = 15%, the dropout rate = 20%. The sample size of each group should be 110, the 220 in total.

Being tested
Mycophenolate Mofetil, Tacrolimus, Glucocorticoid
Keywords
mycophenolate mofetil, tacrolimus, steroid tapering, systemic lupus erythematosus, lupus nephritis
Medical subject headings
Lupus Erythematosus, Systemic, Lupus Nephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mycophenolate MofetilDrug

    Also called MMF

    Participants in steroid tapering group will take MMF+TAC during the first 18 months. After 18 months, participants without lupus flare will randomly stop MMF or TAC.

    Participants in steroid maintenance group will take MMF+TAC during the first 24 months. After 24 months, participants without lupus flare will randomly stop MMF or TAC.

  • TacrolimusDrug

    Also called TAC

    Participants in steroid tapering group will take MMF+TAC during the first 18 months. After 18 months, participants without lupus flare will randomly stop MMF or TAC.

    Participants in steroid maintenance group will take MMF+TAC during the first 24 months. After 24 months, participants without lupus flare will randomly stop MMF or TAC.

  • GlucocorticoidDrug

    Participants in steroid tapering group will stop taking glucocorticoid after the first 6 months.

    Participants in steroid maintenance group will consistently take glucocorticoid for 18 months, and stop the use of glucocorticoid after 18 months if they do not flare.

Study groups in NCT05916781
Study groupRoleWhat they receive
steroid tapering groupExperimental0~6th month: mycophenolate mofetil (1g/d) + tacrolimus (2.0mg/d) + steroid (1 pill/d) 6th~18th month: mycophenolate mofetil (1g/d) + tacrolimus (2.0mg/d) 18th~30th month: Participants who stop steroid treatment and do not flare will be randomly assigned to monotherapy with mycophenolate mofetil or tacrolimus
Receives: Drug: Mycophenolate Mofetil; Drug: Tacrolimus; Drug: Glucocorticoid
steroid maintenance groupActive comparator0~18th month: mycophenolate mofetil (1g/d) + tacrolimus (2.0mg/d) + steroid (1 pill/d) 18th~24th month: Participants who do not flare will stop the use of steroid. 24th~30th month: Participants who do not flare will be randomly assigned to monotherapy with mycophenolate mofetil or tacrolimus
Receives: Drug: Mycophenolate Mofetil; Drug: Tacrolimus; Drug: Glucocorticoid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The 1-year flare rate of lupus nephritis participants who reach the treatment target and accept MMF+TAC remedy tapering steroid in the maintenance period.

    If the DORIS (Definition of Remission In SLE) is not sustained, the patient is considered to have lupus flare.

    Lupus flare can be further evaluated according to SELENA-SLEDAI Flare Index (SFI).

    Lupus nephritis flare can be further evaluated as flare of proteinuria and flare of nephritis.

    Measured: 6th~18th month

Secondary outcomes (7)

  1. The 1-year flare rate of lupus nephritis participants who accept MMF or TAC monotherapy.

    If the DORIS (Definition of Remission In SLE) is not sustained, the patient is considered to have lupus flare.

    Measured: 18th~30th month

  2. Lupus flare (as assessed by SLEDAI and PGA) in SLE patients during the maintenance period after steroid tapering.

    Measured: 6th~30th month

  3. The changes of serum activity markers (anti-dsDNA antibody and C3 level) in SLE patients after steroid tapering.

    Measured: 6th~30th month

  4. Proportion of SLE patients with irreversible organ damage (assessed by SLICC/SDI) after steroid tapering.

    Measured: 6th~30th month

  5. Changes in carotid intima-media thickness after steroid tapering.

    Measured: 6th~30th month

  6. Differences in medical charges between steroid tapering and steroid maintenance patients.

    Obtain the information by questionnaire.

    Measured: 6th~30th month

  7. Differences in health-related quality of life between steroid tapering and steroid maintenance patients.

    Evaluate health-related quality of life by Short-Form Six-Dimension (SF-6D) health index. SF-6D includes 6 dimensions: physical functioning, role limitations, social functioning, pain, mental health, and vitality. The minimum total value is 0. The maximum total value is 1. Higher scores mean a better outcome.

    Measured: 6th~30th month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2023
  2. Study start1 Jul 2023
  3. Primary completion31 Jul 2025 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
First, participants are randomly assigned into 2 groups: steroid tapering group and steroid maintenance group. In steroid tapering group, participants without flare will be assigned into 2 groups: mycophenolate mofetil group and tacrolimus group. In steroid maintenance group, participants without flare will stop the use of steroid for 6 months. Participants without lupus flare after the stop of steroid will be assigned into 2 groups: mycophenolate mofetil group and tacrolimus group.
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05916781
Sponsor's protocol ID
CSTAR008
Status last verified
Jul 2024
First submitted
9 Jun 2023
Last updated
9 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Murimi-Worstell IB, Lin DH, Nab H, Kan HJ, Onasanya O, Tierce JC, Wang X, Desta B, Alexander GC, Hammond ER. Association between organ damage and mortality in systemic lupus erythematosus: a systematic review and meta-analysis. BMJ Open. 2020 May 21;10(5):e031850. doi: 10.1136/bmjopen-2019-031850.

    PubMed 32444429

  • Zonana-Nacach A, Barr SG, Magder LS, Petri M. Damage in systemic lupus erythematosus and its association with corticosteroids. Arthritis Rheum. 2000 Aug;43(8):1801-8. doi: 10.1002/1529-0131(200008)43:83.0.CO;2-O.

    PubMed 10943870

  • Fanouriakis A, Kostopoulou M, Alunno A, Aringer M, Bajema I, Boletis JN, Cervera R, Doria A, Gordon C, Govoni M, Houssiau F, Jayne D, Kouloumas M, Kuhn A, Larsen JL, Lerstrom K, Moroni G, Mosca M, Schneider M, Smolen JS, Svenungsson E, Tesar V, Tincani A, Troldborg A, van Vollenhoven R, Wenzel J, Bertsias G, Boumpas DT. 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus. Ann Rheum Dis. 2019 Jun;78(6):736-745. doi: 10.1136/annrheumdis-2019-215089. Epub 2019 Mar 29.

    PubMed 30926722

  • Tani C, Elefante E, Signorini V, Zucchi D, Lorenzoni V, Carli L, Stagnaro C, Ferro F, Mosca M. Glucocorticoid withdrawal in systemic lupus erythematosus: are remission and low disease activity reliable starting points for stopping treatment? A real-life experience. RMD Open. 2019 Jun 11;5(2):e000916. doi: 10.1136/rmdopen-2019-000916. eCollection 2019.

    PubMed 31275608

  • Mathian A, Pha M, Haroche J, Cohen-Aubart F, Hie M, Pineton de Chambrun M, Boutin THD, Miyara M, Gorochov G, Yssel H, Cherin P, Devilliers H, Amoura Z. Withdrawal of low-dose prednisone in SLE patients with a clinically quiescent disease for more than 1 year: a randomised clinical trial. Ann Rheum Dis. 2020 Mar;79(3):339-346. doi: 10.1136/annrheumdis-2019-216303. Epub 2019 Dec 18.

    PubMed 31852672

  • Villarroel MC, Hidalgo M, Jimeno A. Mycophenolate mofetil: An update. Drugs Today (Barc). 2009 Jul;45(7):521-32. doi: 10.1358/dot.2009.45.7.1384878.

    PubMed 19834629

  • Fanouriakis A, Kostopoulou M, Cheema K, Anders HJ, Aringer M, Bajema I, Boletis J, Frangou E, Houssiau FA, Hollis J, Karras A, Marchiori F, Marks SD, Moroni G, Mosca M, Parodis I, Praga M, Schneider M, Smolen JS, Tesar V, Trachana M, van Vollenhoven RF, Voskuyl AE, Teng YKO, van Leew B, Bertsias G, Jayne D, Boumpas DT. 2019 Update of the Joint European League Against Rheumatism and European Renal Association-European Dialysis and Transplant Association (EULAR/ERA-EDTA) recommendations for the management of lupus nephritis. Ann Rheum Dis. 2020 Jun;79(6):713-723. doi: 10.1136/annrheumdis-2020-216924. Epub 2020 Mar 27.

    PubMed 32220834

  • Mok CC. Mycophenolate mofetil for non-renal manifestations of systemic lupus erythematosus: a systematic review. Scand J Rheumatol. 2007 Sep-Oct;36(5):329-37. doi: 10.1080/03009740701607042.

    PubMed 17963161

  • Broen JCA, van Laar JM. Mycophenolate mofetil, azathioprine and tacrolimus: mechanisms in rheumatology. Nat Rev Rheumatol. 2020 Mar;16(3):167-178. doi: 10.1038/s41584-020-0374-8. Epub 2020 Feb 13.

    PubMed 32055040

  • Yoon KH. Efficacy and cytokine modulating effects of tacrolimus in systemic lupus erythematosus: a review. J Biomed Biotechnol. 2010;2010:686480. doi: 10.1155/2010/686480. Epub 2010 Jun 28.

    PubMed 20625508

  • Hannah J, Casian A, D'Cruz D. Tacrolimus use in lupus nephritis: A systematic review and meta-analysis. Autoimmun Rev. 2016 Jan;15(1):93-101. doi: 10.1016/j.autrev.2015.09.006. Epub 2015 Sep 30.

    PubMed 26427983

  • Zhang H, Liu Z, Zhou M, Liu Z, Chen J, Xing C, Lin H, Ni Z, Fu P, Liu F, Chen N, He Y, Liu J, Zeng C, Liu Z. Multitarget Therapy for Maintenance Treatment of Lupus Nephritis. J Am Soc Nephrol. 2017 Dec;28(12):3671-3678. doi: 10.1681/ASN.2017030263. Epub 2017 Jul 31.

    PubMed 28760751

  • Peng L, Wang Z, Li M, Wang Y, Xu D, Wang Q, Zhang S, Zhao J, Tian X, Zeng X. Flares in Chinese systemic lupus erythematosus patients: a 6-year follow-up study. Clin Rheumatol. 2017 Dec;36(12):2727-2732. doi: 10.1007/s10067-017-3842-z. Epub 2017 Sep 19.

    PubMed 28929239

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mycophenolate Mofetil, Tacrolimus and Glucocorticoid in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by Chinese SLE Treatment And Research Group at 1 site in China.

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 3 inclusion and 7 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 9 Jul 2024. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Can Huang, MD (86-13426191948, huang_can@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The 1-year flare rate of lupus nephritis participants who reach the treatment target and accept MMF+TAC remedy tapering steroid in the maintenance period. (time frame: 6th~18th month). 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 NCT05916781, which also lists 13 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 9 Jul 2024.

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