Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT01741857
Eligibility Criteria:
Inclusion Criteria:
* All patients fulfilled the American College of Rheumatology (ACR) criteria of SLE, man or woman aged from 15 to 60 years old, SLEDAIā„8;
* Lupus nephritis with 24h urine proteinā„1g;
* Refractory disease as determined by failure of the following regimens:
Trial of corticosteroids (oral prednisone more than 20 mg/day); Trial of cyclophosphamide 0.4 \~ 0.6 / m2 every two weeks for six months, or other immunosuppressive drugs, such as mycophenolate mofetil 2 g / day, for three months;
* Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital;
* Willing to use contraception throughout the study and for 12 months following treatment
Exclusion Criteria:
* Abnormal liver function (ALT higher than 3 times the normal value);
* End-stage renal failure;
* Severe heart and pulmonary failure, or other important organs damage;
* Uncontrolled infections
* Pregnant or breast feeding women, male or female who intended to recent pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
60 Years
Study:
NCT01741857
Study Brief:
Protocol Section:
NCT01741857