NCT02839941
Unknown
Not Applicable
An Open-label Study to Evaluate the Effect of Iguratimod Concomitant With Conventional Immunosuppressive Drugs on Preventing Antibody-induced Rejection in Human Leukocyte Antigen(HLA) Highly Mismatched Kidney Transplant Recipients
The First Affiliated Hospital with Nanjing Medical University1 site in 1 country60 target enrollmentStarted: August 2016Last updated:
ConditionsKidney Transplantation
Overview
- Phase
- Not Applicable
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Survival of transplanted kidney
Overview
Brief Summary
The objective of the study is to evaluate the effect of iguratimod concomitant with conventional immunosuppressive drugs on preventing antibody-induced rejection in HLA Highly mismatched Kidney Transplant recipients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female, aged ≥18, \<65 years
- •At least 2 weeks post kidney transplantation from deceased or living donor
- •Stable renal graft function, i.e., serum creatinine undulation for 3 consecutive test \<±10%
- •Serum creatinine\<1.5×upper limits of normal(ULN)
- •Number of HLA mismatches ≥ 4
- •Panel Reactive Antibody(PRA) value pre-transplantation \<10%
- •Concentration of conventional immunosuppressive drugs reach target ranges
- •Subjects are willing to participate in the study, fully informed, and sign informed consent form(ICF)
- •Women of childbearing potential (WOCBP) must have a negative pregnancy test within 24 hours prior to the start of study medication, and agree to use an acceptable method to avoid pregnancy for the entire study period and for up to 3 months after the last dose of study medication.
Exclusion Criteria
- •Pregnant or nursing women
- •Currently clinical acute rejection;
- •Graft function hasn't recovered for delayed graft function (DGF), or primary non-function (PNF)
- •Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas)
- •Subjects with Liver failure
- •Abnormal hepatic, renal and hematopoietic function,
- •Alanine transaminase(ALT), Aspartate transaminase(AST)\>1.5×ULN
- •White blood cell(WBC)\<3.5×10\^9/L
- •Hemoglobin(HGB)\<80 g/L
- •Platelet count(PLT)\<80×10\^9/L.
Arms & Interventions
experiment
Experimental
Intervention: Iguratimod (Drug)
experiment
Experimental
Intervention: Mycophenolate mofetil (Drug)
experiment
Experimental
Intervention: Tacrolimus (Drug)
experiment
Experimental
Intervention: Glucocorticoids (Drug)
Control
Sham Comparator
Intervention: Mycophenolate mofetil (Drug)
Control
Sham Comparator
Intervention: Tacrolimus (Drug)
Control
Sham Comparator
Intervention: Glucocorticoids (Drug)
Outcomes
Primary Outcomes
Survival of transplanted kidney
Time Frame: 52 week
Biopsy-proven acute rejection rates
Time Frame: 0-52 week
Secondary Outcomes
- Donor Specific Antibody(DSA) level compared to baseline(52 week)
- Adverse event(0-52 week)
- Graft renal function(52 week)
Investigators
Study Sites (1)
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