Reference Group Trial for The ONE Study

End-stage Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656135
• Other study ID #: ONErgt11
• Secondary ID: 2606872011-00430
• Status: Completed
• Phase: Phase 4
• First received: July 31, 2012
• Last updated: March 8, 2016
• Start date: December 2012
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéGermany: Federal Institute for Drugs and Medical DevicesItaly: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To investigate the progression of the immunological response in living-donor kidney transplant recipients treated with a standard immunosuppressive regimen. Clinical, immunological, and health-economic data collected during this Reference Group Trial will be used to corroborate historical renal transplantation statistics and generate reference ranges for future clinical studies that will test immunoregulatory cell therapy as an adjunct immunosuppressive treatment in renal transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• End-stage Renal Failure
• Kidney Failure, Chronic
• Kidney Graft Rejection

Intervention

Other:
• Blood drawing for immune monitoring and questionnaires

Locations

Country	Name	City	State
France	CHU de Nantes Hotel-Dieu	Nantes
Germany	Charite Campus Virchow-Klinikum	Berlin
Germany	University Hospital Regensburg	Regensburg
Italy	Ospedale San Raffaele	Milan
United Kingdom	Guy's Hospital in affiliation with King's College London	London
United Kingdom	Churchill Hospital in affiliation with the University of Oxford	Oxford
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Regensburg	European Commission

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immune Monitoring (IM) assessment		60 weeks	No
Other	Health Economics (HEC) assessment		60 weeks	No
Primary	biopsy-confirmed acute rejection incidence		60 weeks	No
Secondary	time to first acute rejection episode		within 60 weeks	No
Secondary	severity of acute rejection episodes		within 60 weeks	No
Secondary	total immunosuppressive burden		60 weeks	No
Secondary	incidence of chronic graft dysfunction		60 weeks	No
Secondary	incidence of graft loss through rejection		60 weeks	No
Secondary	incidence of adverse drug reactions		60 weeks	No
Secondary	incidence of major infections		60 weeks	No
Secondary	incidence of neoplasia		60 weeks	No
Secondary	incidence of patients treated for subclinical acute rejection		60 weeks	No

External Links

•   The ONE Study