Hyperthyroidism as a Potential Predictive of Worse Outcome of Renal Graft

NCT ID: NCT06794203

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-02
• Study Completion Date: 2025-07-01

Brief Summary

The objectives of the study are: to research the association, if any, between the occurrence of thyroid function changes in the immediate post-transplant period and the prognosis of the transplant itself; identify any risk factors for the occurrence of thyroid disorders In the immediate post-transplant period.

Detailed Description

Kidney transplant patients are by definition affected by MRC, regardless of eGFR. However, at the same time, several factors make them a unique category with distant characteristics from non-kidney transplant MRC patients.

Immunosuppressant and corticosteroid therapy could affect a variety of systems, including the pituitary-thyroid-kidney axis. MTOR inhibitors, for example, would result in increased iodine uptake in TSH-stimulated thyrocytes.

Corticosteroids, on the other hand, inhibit the conversion of T4 to T3 and inhibit the TSH production in a dose-dependent manner, and this activity could contribute to the low T3 syndrome that some sturi repot in the phase immediately following kidney transplantation.

In addition, abrupt changes in the serum concentration of thyroid hormones in the immediate post kidney transplantation could be influenced by the stress surgery related to the surgery itself and by exposure to iodinated agents (antiseptics and iodinated contrast medium).

The objectives of the study are:

1. To research the association, if any, between the occurrence of thyroid function changes in the immediate post-transplant period and the prognosis of the transplant itself in terms of:

• Renal function three months after transplantation.
• Medical complications in the post-transplant period (from surgery to patient discharge)
• Patient survival at three months after transplantation.

2. Identify any risk factors for the occurrence of thyroid disorders In the immediate post-transplant period.

During the past 5 years at the Transplant Center of the Nephrology OU, Dialysis, Transplantation of our hospital, 579 kidney transplants have been performed with an average of about 115 transplants per year. It is therefore estimated for our study a sample size of about 100 patients, given the need to meet the inclusion criteria.

Conditions

Kidney Diseases; Kidney Transplant; Hyperthyroidism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Kidney transplant patients

All kidney transplant patients at the U.O. of Nephrology, Dialysis and Transplantation directed by Prof. Gaetano La Manna of the Policlinico Sant'Orsola - IRCCS Azienda Ospedaliero Universitaria of Bologna.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Subjects transplanted at our Center;
• Subjects whose 3-month follow-up is available;
• Age ≥18 years;
• Availability of clinical and laboratory data regarding thyroid function trends in the immediate post-transplant period (within 30 days after transplantation);
• Subjects giving informed consent to participate.

Exclusion Criteria

• None.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gaetano La Manna, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Gaetano La Manna, MD

Role: CONTACT

gaetano.lamanna@unibo.it

+39 051 214 4577

Facility Contacts

Gaetano La Manna, MD

Role: primary

gaetano.lamanna@unibo.it

+390512144577

Other Identifiers

ITTX-21

Identifier Type: -

Identifier Source: org_study_id