Observational Study to Evaluate the Safety and Efficacy of Polyclonal Antibodies in Simultaneous … (NCT03470961) | Clinical Trial Compass
UnknownPhase 4
Observational Study to Evaluate the Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients
China45 participantsStarted 2018-03-01
Plain-language summary
A single-centre, prospective, observational study to evaluate the safety and efficacy of Polyclonal Antibodies in simultaneous Pancreas Kidney Transplant recipients.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.