Back to resultsObservational Study to Evaluate the Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients (PAISPK)
Primary Purpose
CKD (Chronic Kidney Disease) Stage 5T, Diabetes Mellitus, Simultaneous Pancreas Kidney Transplantation
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Anti-Tlymphocyte Globulins
Anti-Thymocyte Globulins
Sponsored by
About this trial
This is an interventional prevention trial for CKD (Chronic Kidney Disease) Stage 5T focused on measuring Grafalon ATG SPK
Eligibility Criteria
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.
- Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
- Patient receives a SPK transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone.
- Donor is older than 55 years of age
- patients with bacterial, viral or mycotic infections which are not under therapeutically control
Sites / Locations
- Tianjin First central hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Anti-Tlymphocyte Globulins
Anti-thymocyte Globulins
Arm Description
intravenous，2mg/kg/d，for 5 days
intravenous，1.5mg/kg/d，for 4 days
Outcomes
Primary Outcome Measures
Incidence and severity of adverse event
Incidence of patient's death,graft loss,acute rejection
Secondary Outcome Measures
Full Information
NCT ID
NCT03470961
First Posted
March 13, 2018
Last Updated
March 13, 2018
Sponsor
Tianjin First Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03470961
Brief Title
Observational Study to Evaluate the Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients
Acronym
PAISPK
Official Title
Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients: Single-centre, Prospective, Observational Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin First Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CKD (Chronic Kidney Disease) Stage 5T, Diabetes Mellitus, Simultaneous Pancreas Kidney Transplantation
Keywords
Grafalon ATG SPK
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anti-Tlymphocyte Globulins
Arm Type
Experimental
Arm Description
intravenous，2mg/kg/d，for 5 days
Arm Title
Anti-thymocyte Globulins
Arm Type
Active Comparator
Arm Description
intravenous，1.5mg/kg/d，for 4 days
Intervention Type
Drug
Intervention Name(s)
Anti-Tlymphocyte Globulins
Other Intervention Name(s)
Grafalon, ATG-F
Intervention Description
Induction therapy regimen in simultaneous pancreas kidney transplantation
Intervention Type
Drug
Intervention Name(s)
Anti-Thymocyte Globulins
Other Intervention Name(s)
ATG
Intervention Description
Induction therapy regimen in simultaneous pancreas kidney transplantation
Primary Outcome Measure Information:
Title
Incidence and severity of adverse event
Description
Incidence of patient's death,graft loss,acute rejection
Time Frame
up to 3 months post-transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
Patient receives a SPK transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone.
Donor is older than 55 years of age
patients with bacterial, viral or mycotic infections which are not under therapeutically control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingxin FU, M.D
Organizational Affiliation
Tianjin First Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin First central hospital
City
Tianjin
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27855166
Citation
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.
Results Reference
result
PubMed Identifier
15814548
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 2:ii33-9, ii62. doi: 10.1093/ndt/gfh1080.
Results Reference
result
Learn more about this trial
Observational Study to Evaluate the Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients
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