Status:
COMPLETED
Autologous Hematopoietic Stem Cell Transplantation for Refractory Lupus Nephritis
Lead Sponsor:
Nanjing University School of Medicine
Conditions:
Lupus Nephritis
Eligibility:
All Genders
14-45 years
Phase:
NA
Brief Summary
In this study, we aimed to evaluate the long term efficacy, remission, survival and safety of autologous hematopoietic stem cell transplantation in patients with refractory lupus nephritis. This is a...
Detailed Description
Treatment plan: Peripheral blood stem cells were mobilized with cyclophosphamide (2.0 g/m2) for 2 days and granulocyte colony-stimulating factor (G-CSF) at 5-10 μg/kg per day was administered when the...
Eligibility Criteria
Inclusion
- 1\. Diagnosed with relapsed and refractory lupus nephritis; 2. Ages from 14 - 45 years old; 3. Serum creatinine \< 2mg/dl; 4. Alanine aminotransferase \< 2 times of normal upper limit; 5. Left ventricular ejection fraction \> 50%; 6. Subjects (or their legal representatives) must signed an informed consent document.
Exclusion
- 1\. Active infection; 2. Known or suspected hypersensitivity to CTX or ATG; 3. Subjects suffering from uncontrolled or severe cardiovascular disease; 4. Subjects suffering from serious physical disease and mental illnesses.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03828071
Start Date
June 1 2011
End Date
December 1 2018
Last Update
February 4 2019
Active Locations (1)
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1
National Clinical Research Center of Kidney Diseases, Jinling Hospital
Nanjing, Jiangsu, China, 210002