Autologous Hematopoietic Stem Cell Transplantation for Refractory Lupus Nephritis

NCT03828071 | Completed

• 1 other identifier: NJCT-1008
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

• Renal remission rate

  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

  seven years

Secondary Outcomes (2)

• renal survival

  seven years

• treatment related mortality

  3 months

Study Arms (1)

stem cell transplantation

OTHER

patients enrolled in this study will received autologous hematopoietic stem cell transplantation as the initial treatment.

Procedure: Autologous hematopoietic stem cell transplantation

Interventions

Autologous hematopoietic stem cell transplantation PROCEDURE

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.

stem cell transplantation

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Nanjing University School of Medicine: lead

Study Sites (1)

National Clinical Research Center of Kidney Diseases, Jinling Hospital

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• zhihong liu, MD

  National Clinical Research Center of Kidney Diseases, Jinling Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 4, 2019
• Study Start: June 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: December 1, 2018
• Last Updated: February 4, 2019

Record last verified: 2019-01

Locations

CN (1)