An observational study in Kidney Diseases, Kidney Transplant and Hyperthyroidism, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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.
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:
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:
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.
969 studies on the registry are indexed under Kidney Diseases; 183 are open to participants now.
This study's planned enrollment of 100 is below the median of 245 across 277 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Thyroid function
To research, if any, the alteration of thyroid function in the immediate post-transplant period
Time frame: At baseline, then 3-month follow-up after kidney transplantation
Renal function
Investigating renal function three months after transplantation.
Time frame: At 3-month follow-up after kidney transplantation
Medical complications
Investigate about medical complications in the post-transplant period
Time frame: Baseline (surgery), at 3-month follow-up after kidney transplantation, at patient discharge
Survival
Patient survival at three months after transplantation.
Time frame: At 3-month follow-up after kidney transplantation
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