The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05114980
Recruitment Status : **RECRUITING NOW**
First Posted : November 10, 2021
Last Update Posted : June 19, 2023
Sponsor:
Information provided by (Responsible Party):
Brenessa Lindeman, University of Alabama at Birmingham
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Brief Summary:
Options for treatment of severe, refractory hypocalcemia are limited for the thousands of patients in the United States who suffer from hypoparathyroidism. Parathyroid allotransplantation is an emerging treatment that provides hope for these individuals. Currently, this therapy has only been successfully provided by a few centers in the world. In the UAB PATH trial, we propose to become one of the few centers worldwide to successfully achieve parathyroid allotransplantation in transplant-naïve patients.
Hypoparathyroidism
Procedure: Parathyroid Allotransplant
Not Applicable
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Study Type :
Interventional (Clinical Trial)
Estimated Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Parathyroid Allotransplantation in Medically Refractory Hypoparathyroidism
Estimated Study Start Date :
July 2024
Estimated Primary Completion Date :
January 2026
Estimated Study Completion Date :
January 2027
Resource links provided by the National Library of Medicine
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Intervention Details:
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Primary Outcome Measures :
Parathyroid transplant function [ Time Frame: 8 weeks post-operatively ]
Detectable PTH
Calcium supplementation [ Time Frame: 6 months post-operatively ]
Amount and type of calcium supplements needed post-operatively
Secondary Outcome Measures :
Serum calcium level [ Time Frame: 6 months post-operatively ]
Immunosuppression-related adverse events [ Time Frame: 12 months post-operatively ]
Infections or other adverse events
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Information from the National Library of Medicine
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Exclusion Criteria:
Any active malignancy, except non-melanoma skin cancer
Dependence on nursing home or other long-term care provider
History of ischemic cardiomyopathy with ejection fraction <20%, uncontrolled diabetes mellitus (Hgb A1c >10), thrombophilia or other clotting or bleeding disorders, significant heart, liver, kidney or central nervous system disease
History of significant psychiatric illness
Severe osteoporosis
Allergy, hypersensitivity, or intolerance of expected immunosuppressive agents (i.e. Thymoglobulin®, tacrolimus, etc.)
Documented history of gross non-adherence to medical therapies
Significant functional/cognitive impairment without reliable caregiver
Presence of active documented systemic infection or recent systemic infection within the past 3 months
Seropositivity for HIV, HBV core antibody or antigen, HCV, HTLV-1
Current smoker (smoking cessation must have occurred 3 months prior to enrollment)
Chemical and/or alcohol dependency or abuse
Psychosocial problems (including alcoholism, drug abuse, documented behavioral disorders)
Resources deemed inadequate to support necessary post-transplant care
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05114980
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University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Contact: Polina Zmijewski, MD 205-975-5000
University of Alabama at Birmingham
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Principal Investigator:
Brenessa Lindeman, MD, MEHP
University of Alabama at Birmingham
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Responsible Party:
Brenessa Lindeman, Associate Professor of Surgery, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT05114980
Other Study ID Numbers:
IRB-3000008285
First Posted:
November 10, 2021 Key Record Dates
Last Update Posted:
June 19, 2023
Last Verified:
June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No
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Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
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HypoparathyroidismParathyroid DiseasesEndocrine System Diseases
Parathyroid HormoneCalcium-Regulating Hormones and AgentsPhysiological Effects of Drugs
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
