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

Diabetes Mellitus Clinical Trial

— PAISPK  

Official title:

Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients: Single-centre, Prospective, Observational Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03470961
• Other study ID #: 2018N017KY
• Status: Active, not recruiting
• Phase: Phase 4
• First received: March 13, 2018
• Last updated: March 13, 2018
• Start date: March 1, 2018
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2018
• Source: Tianjin First Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• CKD (Chronic Kidney Disease) Stage 5T
• Diabetes Mellitus
• Kidney Diseases
• Renal Insufficiency, Chronic
• Simultaneous Pancreas Kidney Transplantation

Intervention

Drug:
• Anti-Tlymphocyte Globulins
Induction therapy regimen in simultaneous pancreas kidney transplantation
• Anti-Thymocyte Globulins
Induction therapy regimen in simultaneous pancreas kidney transplantation

Locations

Country	Name	City	State
China	Tianjin First central hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin First Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Burkhalter F, Schaub S, Bucher C, Gürke 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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse event	Incidence of patient's death,graft loss,acute rejection	up to 3 months post-transplantation