Status:
UNKNOWN
Observational Study to Evaluate the Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients
Lead Sponsor:
Tianjin First Central Hospital
Conditions:
CKD (Chronic Kidney Disease) Stage 5T
Diabetes Mellitus
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
A single-centre, prospective, observational study to evaluate the safety and efficacy of Polyclonal Antibodies in simultaneous Pancreas Kidney Transplant recipients.
Detailed Description
Polyclonal antibody mainly contains Antit-Tlymphocyte globulins(Grafalon) and Anti-thymocyte globulins(ATG). To investigate the efficacy and safety of polyclonal antibodies induction regimen using Gra...
Eligibility Criteria
Inclusion
- with end-stage,diabetic nephropathy(type1or 2)
- Patients scheduled to undergo SPK with compatible ABO blood type.
- Peak PRA \<50%
- Females of childbearing potential must have a negative pregnancy test within 48hrs prior to randomization and reliable methods of contraception should be started 4 weeks prior to and during the whole study.
- Patient must have signed the Patient Informed Consent Form.
- Patient must receive a primary simultaneous pancreas/kidney (SPK) cadaveric transplant, with either intestinal or bladder and either portal or systemic venous drainages.
Exclusion
- Patient is pregnant or breastfeeding.
- Patient has a positive T-cell crossmatch on the most recent serum specimen.
- Patient is known for active liver disease or has significant liver disease, defined by ASAT and ALAT serum levels greater than 3 times the upper limit of normal.
- Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.
- Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomisation.
- Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
- Patient receives a SPK transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone.
- Donor is older than 55 years of age
- patients with bacterial, viral or mycotic infections which are not under therapeutically control
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03470961
Start Date
March 1 2018
End Date
March 1 2021
Last Update
March 20 2018
Active Locations (1)
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1
Tianjin First central hospital
Tianjin, China