Effects of Mycophenolate Mofetil and Cyclophosphamide on Lymphocyte Subsets in Lupus Nephritis
Official title: The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets and Relationship With Relapse
Run by The University of Hong Kong · NCT02954939 · Data updated 2026-11-12
This study is testing whether two different medications, mycophenolate mofetil and cyclophosphamide, can change certain immune cells in people with lupus nephritis to see which treatment works better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | The University of Hong Kong Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Hong Kong) |
| Status | Recruiting |
| Started | March 1, 2017 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | December 16, 2024 |
| Trial ID | NCT02954939 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with biopsy-proven Class III/IV+/-V lupus nephritis and active nephritis.
✕Probably not a fit
Patients who have received certain immunosuppressive therapies or are pregnant or lactating may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates how mycophenolate mofetil (MMF) and cyclophosphamide (CTX) affect lymphocyte subsets in patients diagnosed with proliferative lupus nephritis. Participants with biopsy-proven Class III/IV+/-V lupus nephritis will be randomized to receive either CTX or MMF alongside prednisolone for six months, followed by maintenance therapy. The study will measure lymphocyte subsets and serum cytokine profiles at multiple time points to compare the two treatment regimens and assess their correlation with relapse risk.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with lupus nephritis, potentially reducing relapse rates.
How similar studies have gone: Other studies have shown promising results with similar immunosuppressive approaches in lupus nephritis, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- 1. Patients with biopsy proven Class III/IV+/-V LN (ISN/RPS classification) and active nephritis as indicated by an increase of proteinuria \>1g/day and/or rise in serum creatinine by \>15% compared with baseline, with or without serological reactivation. 2\. Willing to give informed consent Exclusion Criteria: 1. Patients who have received calcineurin inhibitors or proliferation signal inhibitors as maintenance immunosuppression in the preceding 3 months 2. Patients have received biologics therapy (e.g. rituximab, abatacept) in the preceding 12 months 3. Patients who are pregnant or lactating
Where it's running
-
Queen Mary Hospital
Hong Kong, Hong Kong Recruiting
Study contacts
- Study coordinator: Desmond YAP, MD (HK)
- Email: desmondy@hku.hk
- Phone: 22554385
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Triple therapy with voclosporin, MMF and prednisolone in lupus nephritis
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Biomarker tests in adults with lupus to see how kidney disease changes over time
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LUPKYNIS in combination with belimumab, obinutuzumab, or anifrolumab for lupus nephritis
This trial tests whether adding LUPKYNIS to other biologics (belimumab, obinutuzumab, or anifrolumab) plus a mycophenolic acid analog and a steroid can rapidly improve kidney health in adults with biopsy-proven lupus nephritis.
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Mosunetuzumab for people with systemic lupus erythematosus
This study tests mosunetuzumab in people with systemic lupus erythematosus, with or without active lupus nephritis.
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FT819 in Lupus Nephritis: a targeted cell therapy trial for moderate-to-severe LN
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.