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

Tianjin First Central Hospital

Status and phase: Unknown; Phase 4

Conditions: Simultaneous Pancreas Kidney Transplantation; Diabetes Mellitus; CKD (Chronic Kidney Disease) Stage 5T

Treatments: Drug: Anti-Thymocyte Globulins; Drug: Anti-Tlymphocyte Globulins

Study type: Interventional

Funder types: Other

Identifiers

NCT03470961

2018N017KY

Details and patient eligibility

About

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

Full 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 Grafalon compared with ATG in de novo simultaneous pancreas kidney transplant recipients. The primary analysis of this study is to demonstrate the non-inferiority of the two regimens with regard to efficacy, defined as failure rate.

The secondary objective of the study is the assessment of safety and further efficacy parameters in terms of incidence of acute rejections, graft/patient survival, DGF(delayed graft function), pancreas function and renal function

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Anti-Tlymphocyte Globulins

Experimental group

Description:

intravenous，2mg/kg/d，for 5 days

Treatment:

Drug: Anti-Tlymphocyte Globulins

Anti-thymocyte Globulins

Active Comparator group

Description:

intravenous，1.5mg/kg/d，for 4 days

Treatment:

Drug: Anti-Thymocyte Globulins