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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 November 2012 |
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Main ID: |
NCT01203709 |
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Date of registration:
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15/09/2010 |
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Primary sponsor: |
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Public title:
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Low-dose Combination of Mycophenolate Mofetil (MMF) and Tacrolimus (Tac) for Refractory Lupus Nephritis
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Scientific title:
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Low-dose Combination of Mycophenolate Mofetil and Tacrolimus for Refractory Lupus Nephritis: a 12-month Prospective Study |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01203709 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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CC Mok, MD, FRCP |
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Address:
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Telephone:
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(852) 2468 5389 |
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Email:
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ccmok2006@gmail.com |
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Affiliation:
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Name:
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CC Mok, MD, FRCP |
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Address:
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Telephone:
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(852) 2468 5389 |
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Email:
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ccmok2006@gmail.com |
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Affiliation:
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Name:
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CC Mok, MD, FRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tuen Mun Hospital, Hong Kong China |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Active nephritis documented by renal biopsy within 24 months of entry;
2. Failure to respond to 2 or more immunosuppressive regimens which consisted of
high-dose prednisolone combined with other non-corticosteroid immunosuppressive
agents together with ACE inhibitors plus or minus angiotensin receptor blockers (ARB)
for at least 4 months for each regimen at the maximally tolerated drug dosages;
3. Serum creatinine (Scr) less than 200umol/L.
Exclusion Criteria:
1. Previous intolerance to either MMF/Tac;
2. Scr >200umol/L;
3. Informed consent unavailable.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lupus Nephritis
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Intervention(s)
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Drug: low dose combination of MMF and Tac
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Primary Outcome(s)
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Clinical remission rate
[Time Frame: 12 months]
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Secondary Outcome(s)
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Adverse events
[Time Frame: 12 months]
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Secondary ID(s)
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NTWC/CREC/837/10
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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