A Phase 2 interventional study of Mycophenolate mofetil and Azathioprine in Lupus Nephritis, sponsored by Genovate Biotechnology Co., Ltd.,. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-03-03.
Sponsored by Genovate Biotechnology Co., Ltd., · Phase 2, Interventional, and Treatment
This study is designed to compare the safety and efficacy of Mycocep Capsules (Mycophenolate Mofetil) and a marketed Azathioprine formulation, Imuran Azathioprine Tablets, in the maintenance therapy of lupus nephritis.
This study is designed to compare the two different doses of Mycocep Capsules (1.0g/day \& 1.5g/day) and Imuran Azathioprine Tablets (2mg/kg/day), all in combination with low-dose prednisolone (≤10mg/day) as maintenance treatment for lupus nephritis.
340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.
This study's enrollment of 32 is below the median of 48 across 242 interventional studies indexed under Lupus Nephritis.
Browse Lupus Nephritis studies →Genovate Biotechnology Co., Ltd., is the lead sponsor of 13 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mycophenolate mofetil 500mg, PO BID
Drug: Mycophenolate mofetil · Drug: Prednisolone
Mycophenolate mofetil 750mg, PO BID
Drug: Mycophenolate mofetil · Drug: Prednisolone
Azathioprine 1mg/kg, PO BID
Drug: Azathioprine · Drug: Prednisolone
Provided as 250mg/capsule, dose specific for each arm, orally twice a day, for 24 weeks.
Also known as: Mycocep Capsules
Provided as 50mg/tablet, 1mg/kg, orally twice a day, for 24 weeks.
Also known as: Imuran Azathioprine Tablets
Daily dose not more than 10mg, orally, for 24 weeks.
Change in serum albumin
Time frame: 24 weeks treatment
Change in serum creatinine
Time frame: 24 weeks treatment
Change in spot urine protein/creatinine ratio
Time frame: 24 weeks treatment
Change in serum albumin
Time frame: 12 weeks treatment
Change in serum creatinine
Time frame: 12 weeks treatment
Change in spot urine protein/creatinine ratio
Time frame: 12 weeks treatment
Change in cholesterol
Time frame: 24 weeks treatment
Change in triglyceride
Time frame: 24 weeks treatment
Change in complete blood count/differential count (CBC/DC)
Time frame: 24 weeks treatment
Change in number of subjects with doubling of serum creatinine
Time frame: 24 weeks treatment
Change in the average daily dose of oral prednisolone
Time frame: 24 weeks treatment
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Jul 2015, a primary completion of Dec 2016 and a completion of Jan 2017. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mycophenolic Acid
Genovate Biotechnology Co., Ltd.,