ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 21 of 1494 for:    "Kidney Failure, Chronic"

Pilot Feasibility Study of Combined Kidney and Hematopoietic Stem Cell Transplantation to Cure End-stage Renal Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02176434
Recruitment Status : Recruiting
First Posted : June 27, 2014
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
This pilot study of combined kidney and hematopoietic stem cell transplantation attempts to establish a protocol to induce immunological tolerance as a new strategy to prevent renal graft rejection. If successful, this strategy would restore renal function, while avoiding the risks associated with long-term standard anti-rejection therapy, and would represent the first option to cure end-stage renal disease.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Procedure: Kidney and hematopoietic stem cell transplantation Biological: hematopoietic stem cell Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Feasibility Study of Combined Kidney and Hematopoietic Stem Cell Transplantation to Cure End-stage Renal Disease
Study Start Date : September 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tolerance
Combined kidney and hematopoietic stem cell transplantation from the same donor.
Procedure: Kidney and hematopoietic stem cell transplantation
Kidney transplantation (day 0) Induction therapy (s. above) Hematopoietic stem cell transplantation (s. above)

Biological: hematopoietic stem cell



Primary Outcome Measures :
  1. Renal allograft acceptance and ability to discontinue immunosuppressive therapy at 1 year [ Time Frame: 1 year ]
    • Renal function as determined by eGFR (CKD-EPI) and proteinuria after discontinuation of immunosuppressive therapy (1 year after transplantation)
    • Evidence for rejection according to Banff classification, as assessed in the transplant biopsy performed after discontinuation of immunosuppressive therapy (1 year after transplantation)


Secondary Outcome Measures :
  1. Engraftment of hematopoietic stem cells (chimerism) [ Time Frame: 6 months ]
    Hematopoietic chimerism will be determined by measurement of donor-derived cells in peripheral blood

  2. Absence of graft versus host disease [ Time Frame: 6 and 12 months ]
    Presence and grade of graft versus host disease will be assessed by clinical evaluation

  3. Absence of renal allograft rejection [ Time Frame: 6 and 12 months ]
    Renal allograft rejection will be assessed by measurement of renal function (eGFR CKD-EPI) and proteinuria in kidney transplant biopsy performed at 6 months and 1 year after transplantation

  4. T cell recovery and immune reconstitution [ Time Frame: 6 and 12 months ]
    T cell recovery and immune reconstitution will be measured by FACS analysis of peripheral blood samples and by functional immunological tests in vitro (T cell proliferation, T cell toxicity)

  5. Absence of opportunistic infections (immune competence) [ Time Frame: 6 and 12 months ]
    Opportunistic infections will be monitored clinically as a surrogate of immune competence

  6. Quality of life [ Time Frame: 6 and 12 months ]
    Quality of life will be assessed by a standardized validated questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients, who are eligible for kidney transplantation
  • Males or females 18 - 70 years of age.
  • Subjects must have an HLA-matched sibling donor 25-70 years of age
  • Men and women of reproductive potential must agree to use a reliable method of birth control
  • Ability to understand and provide informed consent.

Exclusion Criteria:

  • Evidence of uncontrolled active infection (including replicating HIV, Hepatitic B and Hepatitis C) as defined by:

    1. clinical syndrome consistent with viral or bacterial infection, or
    2. fever with a clinical site of infection identified, or
    3. microbiologically documented infection
  • Contraindication to therapy with any one of the proposed agents (e.g. allergy to ATG).
  • Serologic positivity to HIV.
  • Women of childbearing age in whom adequate contraception cannot be maintained, pregnant women or nursing mothers.
  • Malignancy within the past two years, for which waiting time for transplantation is required by PENN registry consult, thereby excluding non-melanoma skin cancer and carcinoma in situ of the cervix.
  • Liver transaminases > 3 x normal value.
  • Cardiac ejection fraction < 50% by radionuclide ventriculography or echocardiography.
  • Forced Expiratory Volume (FEV1) < 50% predicted or corrected Diffusing Capacity for Carbon Monoxide (DLCO) < 50 % predicted.
  • Blood group incompatibility in the host-vs-graft direction.
  • Panel Reactive Antibody (PRA) > 20%
  • High risk of primary kidney disease recurrence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02176434


Contacts
Contact: Thomas Fehr, MD thomas.fehr@uzh.ch

Locations
Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland, CH-8091
Contact: Thomas Fehr, MD       thomas.fehr@uzh.ch   
Principal Investigator: Thomas Fehr, MD         
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Thomas Ferh, MD University of Zurich

Publications:
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02176434     History of Changes
Other Study ID Numbers: swisstolerance.ch
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Zurich:
End stage renal disease
Transplantation
Tolerance

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency