Parathyroid Allotransplantation in Medically Refractory Hypoparathyroidism (PATH)
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ClinicalTrials.gov Identifier: NCT05114980 |
Recruitment Status :
Recruiting
First Posted : November 10, 2021
Last Update Posted : June 18, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypoparathyroidism | Procedure: Parathyroid Allotransplant | Not Applicable |
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 |
- Procedure: Parathyroid Allotransplant
Patients that meet inclusion criteria and are enrolled in the trial will undergo parathyroid allotransplantation
- 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
- 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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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Individual diagnosed with hypocalcemia secondary to
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Hypoparathyroidism:
- Prior anterior cervical neck surgery resulting in hypoparathyroidism
- Congenital absence or malformation of parathyroid glands during development
- Presence of hypoparathyroidism for at least one year
- Failure of medical treatment for hypocalcemia, including need for IV calcium, with negative impact on quality of life and daily function
- Age 18-80 years
- Lives in the greater Birmingham region for the duration of the trial
- Fluent in the English Language
- Willing to comply with screening, protocol and all required procedures
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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
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
Contact: Polina Zmijewski, MD | 205-934-3333 | pzmijewski@uabmc.edu | |
Contact: Brenessa Lindeman, MD, MEHP | 205-975-5000 | blindeman@uabmc.edu |
United States, Alabama | |
University of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Polina Zmijewski, MD 205-975-5000 |
Principal Investigator: | Brenessa Lindeman, MD, MEHP | University of Alabama at Birmingham |
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 18, 2023 |
Last Verified: | June 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypoparathyroidism Parathyroid Diseases Endocrine System Diseases |
Parathyroid Hormone Calcium-Regulating Hormones and Agents Physiological Effects of Drugs |