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NCT Number: NCT06794203

Hyperthyroidism as a Potential Predictive of Worse Outcome of Renal Graft

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, 40138, Italy

Location status: Recruiting

Location contact

Gaetano La Manna, MD

CONTACT

[email protected]

+390512144577

About this study

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:
  • 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.
  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Thyroid function

    Time frame: At baseline, then 3-month follow-up after kidney transplantation

    To research, if any, the alteration of thyroid function in the immediate post-transplant period

  2. Renal function

    Time frame: At 3-month follow-up after kidney transplantation

    Investigating renal function three months after transplantation.

  3. Medical complications

    Time frame: Baseline (surgery), at 3-month follow-up after kidney transplantation, at patient discharge

    Investigate about medical complications in the post-transplant period

  4. Survival

    Time frame: At 3-month follow-up after kidney transplantation

    Patient survival at three months after transplantation.

Study contacts

Contact information is provided by the study sponsor or research team.

Gaetano La Manna, MD

CONTACT

[email protected]

+39 051 214 4577

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Hyperthyroidism in the Immediate Post-kidney Transplantation Period: a Potential Predictive of Worse Outcome of Renal Graft

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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