Clinical trial NCT06794203: Hyperthyroidism as a Potential Predictive of Worse Outcome of Renal Graft
Official title: Hyperthyroidism in the Immediate Post-kidney Transplantation Period: a Potential Predictive of Worse Outcome of Renal Graft
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Diseases
Kidney Transplant
Hyperthyroidism
Keywords: Hyperthyroidism
Kidney Diseases
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All kidney transplant patients at the U.O. of Nephrology, Dialysis and Transplantation directed by Prof. Gaetano La Manna of Policlinico Sant'Orsola - IRCCS Azienda Ospedaliero Universitaria di Bologna.

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.

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.

Primary outcomes:
measure: Thyroid function
timeFrame: At baseline, then 3-month follow-up after kidney transplantation
measure: Renal function
timeFrame: At 3-month follow-up after kidney transplantation
measure: Medical complications
timeFrame: Baseline (surgery), at 3-month follow-up after kidney transplantation, at patient discharge
measure: Survival
timeFrame: At 3-month follow-up after kidney transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
state: BO
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Gaetano La Manna, MD
role: PRINCIPAL_INVESTIGATOR
References: