Hyperthyroidism as a Potential Predictive of Worse Outcome of Renal Graft

Hyperthyroidism in the Immediate Post-kidney Transplantation Period: 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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Diseases; Hyperthyroidism; Kidney Transplant

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Gaetano La Manna, MD; Phone Number: +39 051 214 4577; Email: gaetano.lamanna@unibo.it

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • Recruiting
      • IRCCS Azienda Ospedaliero-Universitaria di Bologna
      • Contact: Gaetano La Manna, MD; Phone Number: +390512144577; Email: gaetano.lamanna@unibo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thyroid function	To research, if any, the alteration of thyroid function in the immediate post-transplant period	At baseline, then 3-month follow-up after kidney transplantation
Renal function	Investigating renal function three months after transplantation.	At 3-month follow-up after kidney transplantation
Medical complications	Investigate about medical complications in the post-transplant period	Baseline (surgery), at 3-month follow-up after kidney transplantation, at patient discharge
Survival	Patient survival at three months after transplantation.	At 3-month follow-up after kidney transplantation

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Gaetano La Manna, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2022
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Kidney Diseases; Hyperthyroidism
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Thyroid Diseases; Kidney Diseases; Hyperthyroidism
• Other Study ID Numbers: ITTX-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No