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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
Sponsor:
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine

Tracking Information
First Submitted Date  ICMJE January 30, 2019
First Posted Date  ICMJE February 4, 2019
Last Update Posted Date February 4, 2019
Actual Study Start Date  ICMJE June 1, 2011
Actual Primary Completion Date January 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Hematopoietic Stem Cell Transplantation for Refractory Lupus Nephritis
Official Title  ICMJE National Clinical Research Center of Kidney Diseases, Jinling Hospital
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 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.

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 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 (usually 11 days after cyclophosphamide). The target acquisition was CD34+ cells > 2×10^6/kg and mononuclear cells > 2×10^8/kg. The graft was preserved at a temperature of -196 ℃ for further use. 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. Methylprednisolone (80-500 mg/day) was administered through intravenous drip at the same time with ATG to reduce anaphylaxis. The incidence of drug-related complications was decreased by hyperhydration (the volume of infusion liquid is 50 ml/kg/day), urine alkalization (infusion of sodium bicarbonate 250ml/day), and anti-emetic medication. G-CSF (0.5 μg/kg/d) was administered to each patient beginning the day after stem cells reinfusion until the level of absolute peripheral neutrophil count was consecutively higher than 1.0 × 10^9/L.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lupus Nephritis
Intervention  ICMJE 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.

Study Arms  ICMJE stem cell transplantation
patients enrolled in this study will received autologous hematopoietic stem cell transplantation as the initial treatment.
Intervention: Procedure: Autologous hematopoietic stem cell transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2019)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1, 2018
Actual Primary Completion Date January 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03828071
Other Study ID Numbers  ICMJE NJCT-1008
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhi-Hong Liu, M.D., Nanjing University School of Medicine
Study Sponsor  ICMJE Nanjing University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: zhihong liu, MD National Clinical Research Center of Kidney Diseases, Jinling Hospital
PRS Account Nanjing University School of Medicine
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP