Combining kidney and stem cell transplants to treat end-stage renal disease

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

This study is testing if combining kidney transplants with stem cell transplants can help people with end-stage kidney disease avoid taking long-term medications to prevent organ rejection.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: University of Zurich (other)
• Drugs / interventions: prednisone
• Locations: 1 site (Zurich)
• Trial ID: NCT02176434 on ClinicalTrials.gov

What this trial studies

This pilot study explores the feasibility of combining kidney transplantation with hematopoietic stem cell transplantation to induce immunological tolerance and prevent renal graft rejection. Conducted at the University Hospital of Zurich, the study will involve 5 to 8 donors and recipients, aiming for a significant number of recipients to remain off immunosuppressive therapy within 6-12 months post-transplant. Participants will undergo thorough screening and specific pre-transplant interventions, including total lymphoid irradiation and leukapheresis. The goal is to establish a new protocol that could potentially cure end-stage renal disease.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18-70 with end-stage renal disease who have an HLA-matched sibling donor.

Not a fit: Patients with uncontrolled infections, certain allergies, or recent malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a cure for end-stage renal disease while minimizing the risks associated with long-term anti-rejection medications.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in the field of transplantation, indicating potential for success.

Eligibility 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.
* High risk of primary kidney disease recurrence

Where this trial is running

Zurich

• University Hospital Zurich — Zurich, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Thomas Ferh, MD — University of Zurich
• Study coordinator: Thomas Fehr, MD

Conditions: End Stage Renal Disease, End stage renal disease, Transplantation, Tolerance