Recruiting

DSA Monitoring

Sponsor:

Providence Health & Services

Code:

NCT01382355

Conditions

Kidney Transplant

Kidney/Pancreas Transplant

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Advances in transplant pharmacotherapy have led to improved one-year patient and graft survival in kidney transplant recipients, but have not translated to enhanced long-term survival. An explanation for the disparity in outcomes is the negative role of antibodies in transplant graft survival. There currently does not exist maintenance immunosuppression that targets antibodies and standard of practice aims at removing circulating donor specific antibodies upon detection of antibody mediated graft damage but not prior to the detection of rejection. There exists an insufficiency of data regarding patient and donor characteristics, changes in immunosuppression, the risk of viral donor and patient seropositivity and the risk of non-compliance on the development of antibodies. By measuring antibody levels in the blood at specific time periods after transplant, we may have a better understanding of what types of patients will develop antibodies, when these antibodies appear and how changes to transplant medications may affect antibodies.

The proposed project will examine the multifactorial risks associated with the development and appearance of donor-specific antibodies in the first year post-kidney transplant. The data collected will provide a historical perspective and preliminary pilot data to support a proposal for prospective antibody monitoring and to justify pre-emptively treating the antibodies in the absence of clinical signs of rejection.

Conditions

Kidney Transplant

Kidney/Pancreas Transplant

Study ID

NCT01382355

Start date

Aug, 2011

Status verified date

Aug, 2011

Completion date

Aug, 2012

Anticipated

Primary completion date

Aug, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Have received a living donor or deceased donor kidney/kidney pancreas transplant

Exclusion Criteria:

  • Have not received a transplant

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Kidney transplant

Primary outcome measure

  • Proportion of patients who develop DSA within the first year post-transplant [ Time Frame: 1 year ]
  • Risk factors for developing DSA [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

Providence Sacred Heart Medical Center

Recruiting

Spokane, Washington, United States, 99204

Contacts

More Information

Sponsor

Providence Health & Services

Last update posted

Aug 4, 2011

Last verified

Aug, 2011

Keywords

  • Kidney transplant
  • Kidney/Pancreas transplant
  • Antibody
  • Monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Providence Health & Services on 2011-08-04.