A Study to Evaluate the Risk of Adverse Renal Events When a Renal Transplant Recipient Becomes Pregnant
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-010422
Sponsor Protocol Number: 18-010422
About this study
The purpose of this study is to test the hypothesis that pregnancy post-transplant will increase the risk of adverse renal events (defined as acute rejection, reduction in GFR by 30%, new or worsening proteinuria, or graft-loss). The risk will be increased in women with complications in pregnancy, such as preeclampsia or pre-term delivery.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- All women transplanted at Mayo Clinic (all 3 sites).
- Ages 18-44 at time of transplant.
- Transplant from 1/1/1996 to 12/31/2014, with grafts that functioned for 2 years. This will include recipients of dual organ transplantation.
Exclusion Criteria:
Graft functioning for less than 2 years after transplant.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Andrea Kattah, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available