Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-28 @ 4:11 PM
Study NCT ID:
NCT06794203
Status:
RECRUITING
Last Update Posted:
2025-01-27
First Post:
2024-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperthyroidism as a Potential Predictive of Worse Outcome of Renal Graft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2024-12-30', 'studyFirstSubmitQcDate': '2025-01-24', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thyroid function', 'timeFrame': 'At baseline, then 3-month follow-up after kidney transplantation', 'description': 'To research, if any, the alteration of thyroid function in the immediate post-transplant period'}, {'measure': 'Renal function', 'timeFrame': 'At 3-month follow-up after kidney transplantation', 'description': 'Investigating renal function three months after transplantation.'}, {'measure': 'Medical complications', 'timeFrame': 'Baseline (surgery), at 3-month follow-up after kidney transplantation, at patient discharge', 'description': 'Investigate about medical complications in the post-transplant period'}, {'measure': 'Survival', 'timeFrame': 'At 3-month follow-up after kidney transplantation', 'description': 'Patient survival at three months after transplantation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyperthyroidism', 'Kidney Diseases'], 'conditions': ['Kidney Diseases', 'Kidney Transplant', 'Hyperthyroidism']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nImmunosuppressant 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.\n\nCorticosteroids, 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.\n\nIn 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).\n\nThe objectives of the study are:\n\n1. 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:\n\n * Renal function three months after transplantation.\n * Medical complications in the post-transplant period (from surgery to patient discharge)\n * Patient survival at three months after transplantation.\n2. Identify any risk factors for the occurrence of thyroid disorders In the immediate post-transplant period.\n\nDuring 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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.", 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects transplanted at our Center;\n* Subjects whose 3-month follow-up is available;\n* Age ≥18 years;\n* Availability of clinical and laboratory data regarding thyroid function trends in the immediate post-transplant period (within 30 days after transplantation);\n* Subjects giving informed consent to participate.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT06794203', 'briefTitle': 'Hyperthyroidism as a Potential Predictive of Worse Outcome of Renal Graft', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Hyperthyroidism in the Immediate Post-kidney Transplantation Period: a Potential Predictive of Worse Outcome of Renal Graft', 'orgStudyIdInfo': {'id': 'ITTX-21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Kidney transplant patients', 'description': "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."}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'BO', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gaetano La Manna, MD', 'role': 'CONTACT', 'email': 'gaetano.lamanna@unibo.it', 'phone': '+390512144577'}], 'facility': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Gaetano La Manna, MD', 'role': 'CONTACT', 'email': 'gaetano.lamanna@unibo.it', 'phone': '+39 051 214 4577'}], 'overallOfficials': [{'name': 'Gaetano La Manna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}