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

NCT ID: NCT03470961

Last Updated: 2018-03-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2021-03-01

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 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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Anti-Tlymphocyte Globulins

intravenous，2mg/kg/d，for 5 days

Group Type: EXPERIMENTAL

Anti-Tlymphocyte Globulins

Intervention Type: DRUG

Induction therapy regimen in simultaneous pancreas kidney transplantation

Anti-thymocyte Globulins

intravenous，1.5mg/kg/d，for 4 days

Group Type: ACTIVE_COMPARATOR

Anti-Thymocyte Globulins

Intervention Type: DRUG

Induction therapy regimen in simultaneous pancreas kidney transplantation

Interventions

Anti-Tlymphocyte Globulins

Induction therapy regimen in simultaneous pancreas kidney transplantation

Intervention Type: DRUG

Anti-Thymocyte Globulins

Induction therapy regimen in simultaneous pancreas kidney transplantation

Intervention Type: DRUG

Other Intervention Names

Grafalon; ATG-F; ATG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin First Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yingxin FU.MD

Head of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yingxin FU, M.D

Role: PRINCIPAL_INVESTIGATOR

Tianjin First Central Hospital

Locations

Tianjin First central hospital

Tianjin, , China

Countries

China

References

Burkhalter F, Schaub S, Bucher C, Gurke L, Bachmann A, Hopfer H, Dickenmann M, Steiger J, Binet I. A Comparison of Two Types of Rabbit Antithymocyte Globulin Induction Therapy in Immunological High-Risk Kidney Recipients: A Prospective Randomized Control Study. PLoS One. 2016 Nov 17;11(11):e0165233. doi: 10.1371/journal.pone.0165233. eCollection 2016.

Reference Type: RESULT

PMID: 27855166 (View on PubMed)

Kuypers DR, Malaise J, Claes K, Evenepoel P, Maes B, Coosemans W, Pirenne J, Vanrenterghem Y; Euro-SPK Study Group. Secondary effects of immunosuppressive drugs after simultaneous pancreas-kidney transplantation. Nephrol Dial Transplant. 2005 May;20 Suppl 2:ii33-9, ii62. doi: 10.1093/ndt/gfh1080.

Reference Type: RESULT

PMID: 15814548 (View on PubMed)

Other Identifiers

2018N017KY

Identifier Type: -

Identifier Source: org_study_id