Observational Study to Evaluate the Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients

• Status: Unknown status
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A single-centre, prospective, observational study to evaluate the safety and efficacy of Polyclonal Antibodies in simultaneous Pancreas Kidney Transplant recipients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin First Central Hospital
• Treatments: Antibodies; Antilymphocyte Serum; Pancreatin; Pancrelipase

Criteria

Inclusion Criteria:

1. with end-stage,diabetic nephropathy(type1or 2)

2. Patients scheduled to undergo SPK with compatible ABO blood type.

3. Peak PRA <50%

4. 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.

5. Patient must have signed the Patient Informed Consent Form.

6. 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:

1. Patient is pregnant or breastfeeding.

2. Patient has a positive T-cell crossmatch on the most recent serum specimen.

3. 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.

4. Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.

5. Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomisation.

6. Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.

7. Patient receives a SPK transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone.

8. Donor is older than 55 years of age

9. patients with bacterial, viral or mycotic infections which are not under therapeutically control