NCT06794203

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2022

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

January 27, 2025

Status Verified

December 1, 2024

Enrollment Period

2.8 years

First QC Date

December 30, 2024

Last Update Submit

January 24, 2025

Conditions

Keywords

HyperthyroidismKidney Diseases

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Kidney DiseasesHyperthyroidism

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesThyroid DiseasesEndocrine System Diseases

Study Officials

  • Gaetano La Manna, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaetano La Manna, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2024

First Posted

January 27, 2025

Study Start

September 2, 2022

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

January 27, 2025

Record last verified: 2024-12

Locations