Autologous Hematopoietic Stem Cell Transplantation for Refractory Lupus Nephritis
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|ClinicalTrials.gov Identifier: NCT03828071|
Recruitment Status : Completed
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
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 an single arm, non-randomized study. Patients who were diagnosed with relapsed and refractory lupus nephritis would included in this study. Refractory lupus nephritis is defined as no response to at least one type of immunosuppressant therapy (including corticosteroids, cyclophosphamide, tacrolimus, mycophenolate mofetil and cyclosporine) for more than six months, or relapse during the period maintenance therapy with kidney pathological transformation or persistently positive antibodies. Close observation was carried out at stem cell harvest, at transplantation, at 3, 6, 12, 18, and 24 months and then once a year after autologous stem cell transplantation.
20-30 cases will be included in this study.
|Condition or disease||Intervention/treatment||Phase|
|Lupus Nephritis||Procedure: Autologous hematopoietic stem cell transplantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||National Clinical Research Center of Kidney Diseases, Jinling Hospital|
|Actual Study Start Date :||June 1, 2011|
|Actual Primary Completion Date :||January 1, 2015|
|Actual Study Completion Date :||December 1, 2018|
stem cell transplantation
patients enrolled in this study will received autologous hematopoietic stem cell transplantation as the initial treatment.
Procedure: Autologous hematopoietic stem cell transplantation
Stem cell mobilization and collection: 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 level of peripheral leucocytes was < 1×109/L. Peripheral leukocyte counts were monitored, and harvesting was performed when the peripheral white blood cell level rebounded .
Conditioning and reinfusion of stem cells: The conditioning regimen consisted of intravenous cyclophosphamide (40 mg/kg/day × 4 days) 5 days before transplantation (a total dose 160 mg/kg) and rabbit antithymocyte globulin (ATG) (2.5mg/kg/day × 3 days) 4 days before transplantation. The dose of cyclophosphamide and ATG could be reduced according to the patients' condition.
- Renal remission rate [ Time Frame: seven years ]The curative effect on the kidney was defined as follows: complete remission: proteinuria< 0.4 g/24 h, red blood cell (RBC) < 3/HP in urine sediment, serum albumin > 3.5g/dl and serum creatinine < 1.24 mg/dl; partial remission: 50% baseline < decrease of proteinuria < 3.5 g/24 h, serum albumin >30g/L and serum creatinine < 1.24 mg/dl, no remission (NR): failed to achieve partial remission
- renal survival [ Time Frame: seven years ]the time from treatment start to dialysis.
- treatment related mortality [ Time Frame: 3 months ]patients who dies in 3 months after treatment start.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828071
|National Clinical Research Center of Kidney Diseases, Jinling Hospital|
|Nanjing, Jiangsu, China, 210002|
|Principal Investigator:||zhihong liu, MD||National Clinical Research Center of Kidney Diseases, Jinling Hospital|