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Reference Group Trial for The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation


Phase 4
18 Years
N/A
Open (Enrolling)
Both
End-stage Renal Failure, Kidney Graft Rejection

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Trial Information

Reference Group Trial for The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation


Inclusion Criteria:



Organ Donor:

A prospective donor is eligible for the research if all of the following inclusion
criteria apply:

1. Eligible for live kidney donation

2. Aged at least 18 years

3. An ABO blood type compatible with the organ recipient

4. Willing and able to provide a blood sample for The ONE Study Subprojects

5. Willing to provide personal and medical/biological data for the trial

6. Signed and dated written informed consent.

In signing the donor information sheet/informed consent form (DIS/ICF), organ donors agree
to provide a blood sample for the IM Subproject, and permit access to their medical
records for the collection of specified demographic and medical/biological data for the
trial.

Organ Recipient:

1. Chronic renal insufficiency necessitating kidney transplantation and approved to
receive a primary kidney allograft from a living donor

2. Aged at least 18 years

3. Able to commence the immunosuppressive regimen at the protocol-specified time point

4. Willing and able to participate in The ONE Study subprojects

5. Signed and dated written informed consent.

Exclusion Criteria:

Organ Donor:

If a prospective donor fulfils any of the following criteria, then they are ineligible for
the trial:

1. Genetically identical to the prospective organ recipient at the HLA loci

2. Exposure to any investigational agents at the time of kidney donation, or within 28
days prior to kidney donation

3. Any form of substance abuse, psychiatric disorder, or other condition that, in the
opinion of the Investigator, may invalidate communication with the Investigator
and/or designated study personnel

4. Subjects unable to freely give their informed consent (e.g. individuals under legal
guardianship).

Organ Recipient:

1. Patient has previously received, or is scheduled to receive, any tissue or organ
transplant other than the planned kidney graft

2. Known sensitivity to tacrolimus, mycophenolate, or corticosteroids

3. Genetically identical to the prospective organ donor at the HLA loci

4. PRA grade > 40% within 6 months prior to enrolment

5. Previous treatment with any desensitisation procedure (with or without IVIg)

6. Concomitant malignancy or history of malignancy within 5 years prior to planned study
entry (excluding successfully-treated non-metastatic basal/squamous cell carcinoma of
the skin)

7. Evidence of significant local or systemic infection

8. HIV-positive, EBV-negative or suffering chronic viral hepatitis

9. Significant liver disease, defined as persistently elevated AST and/or ALT levels >2
x ULN (Upper Limit of Normal range)

10. Malignant or pre-malignant haematological conditions

11. Any uncontrolled medical condition or concurrent disease that could interfere with
the study objectives

12. Any condition which, in the judgement of the Investigator, would place the subject at
undue risk

13. Ongoing treatment with systemic immunosuppressive drugs at study entry

14. Participation in another clinical trial during the study or within 28 days prior to
planned study entry

15. Female patients of child-bearing potential with a positive pregnancy test at
enrolment

16. Female patients who are breast-feeding

17. All female patients of child-bearing potential UNLESS:

1. The patient is willing to maintain a highly effective method of birth control
for the duration of the study

2. The career, lifestyle, or sexual orientation of the patient ensures that there
is no risk of pregnancy for the duration of the study (at the discretion of the
local Investigator)

18. Psychological, familial, sociological or geographical factors potentially hampering
compliance with the study protocol and follow-up visit schedule

19. Any form of substance abuse, psychiatric disorder, or other condition that, in the
opinion of the Investigator, may invalidate communication with the Investigator
and/or designated study personnel

20. Patients unable to freely give their informed consent (e.g. individuals under legal
guardianship).

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

biopsy-confirmed acute rejection incidence

Outcome Time Frame:

60 weeks

Safety Issue:

No

Principal Investigator

Edward K. Geissler, Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

University of Regensburg

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

ONErgt11

NCT ID:

NCT01656135

Start Date:

December 2012

Completion Date:

November 2015

Related Keywords:

  • End-stage Renal Failure
  • Kidney Graft Rejection
  • gold standard treatment
  • immune monitoring
  • acute rejection
  • graft rejection
  • living-donor
  • renal transplantation
  • kidney transplantation
  • Kidney Failure, Chronic
  • Renal Insufficiency

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617
Connie Frank Transplant CenterSan Francisco, California  94143