Effects of Mycophenolate Mofetil and Cyclophosphamide on Lymphocyte Subsets in Lupus Nephritis
The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets and Relationship With Relapse
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT02954939 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with biopsy-proven Class III/IV+/-V lupus nephritis and active nephritis.
Not a fit: Patients who have received certain immunosuppressive therapies or are pregnant or lactating may not benefit from this study.
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 performed: Other studies have shown promising results with similar immunosuppressive approaches in lupus nephritis, indicating potential for success.
Eligibility criteria
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 this trial is running
Hong Kong
- Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Desmond YAP, MD (HK)
- Email: desmondy@hku.hk
- Phone: 22554385
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.