Combining Mycophenolate Mofetil and Tacrolimus to Reduce Steroid Use in Lupus Patients
Effectiveness of Mycophenolate Mofetil Combined With Tacrolimus for Steroid Tapering in Systemic Lupus Erythematosus: A Prospective, Random Control, Open-label, Single Center Clinical Trial
This study is testing if combining two medications, mycophenolate mofetil and tacrolimus, can help people with lupus nephritis stay in remission while reducing their use of steroids.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Chinese SLE Treatment And Research Group Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05916781 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of mycophenolate mofetil (MMF) combined with tacrolimus (TAC) in maintaining remission for patients with lupus nephritis who are tapering off steroids. Participants will be randomly assigned to either a steroid tapering group, receiving MMF and TAC without steroids, or a steroid maintenance group, continuing with MMF or TAC alongside low-dose steroids. The study aims to evaluate the safety, tolerability, and efficacy of this combination therapy over a two-year follow-up period, while also assessing health economics and potential impacts on carotid intima thickness. The trial will include a total of 220 participants, with a focus on achieving non-inferiority in flare rates between the two groups.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with systemic lupus erythematosus and lupus nephritis who have achieved treatment targets and are currently on low-dose steroids.
Not a fit: Patients who are not in remission or those who have not reached the specified treatment targets may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help reduce steroid use in lupus patients while maintaining remission, potentially minimizing steroid-related side effects.
How similar studies have performed: Other studies have shown promising results with similar approaches in managing lupus, but this specific combination therapy is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Beijing
- Peking Union Medical College Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Can Huang, MD
- Email: huang_can@yeah.net
- Phone: 86-13426191948
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.