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Procedure
Parathyroid Transplant for Hypoparathyroidism (PATH Trial)
N/A
Recruiting
Led By Brenessa Lindeman, MD, MEHP
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individual diagnosed with hypocalcemia secondary to hypoparathyroidism due to prior anterior cervical neck surgery resulting in hypoparathyroidism
Individual diagnosed with hypocalcemia secondary to hypoparathyroidism due to congenital absence or malformation of parathyroid glands during development
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-operatively
Awards & highlights
PATH Trial Summary
This trial is for people with a severe, yet treatable, case of low calcium levels. The transplant would be coming from a donor.
Who is the study for?
This trial is for adults aged 18-80 with hypoparathyroidism caused by neck surgery, congenital issues, or treatment failure. They must have had the condition for at least a year and live near Birmingham. Participants need to speak English and commit to the trial's process. Exclusions include active cancer (except skin), severe heart/liver/kidney/brain diseases, uncontrolled diabetes, clotting disorders, psychiatric illness, osteoporosis, allergies to immunosuppressants, non-adherence to medical therapies.Check my eligibility
What is being tested?
The UAB PATH trial is testing parathyroid allotransplantation as a new treatment option for patients with medically refractory hypocalcemia due to hypoparathyroidism. This innovative procedure aims to provide relief where other treatments have failed.See study design
What are the potential side effects?
Potential side effects may include reactions related to immunosuppressive drugs such as Thymoglobulin® and tacrolimus like increased infection risk, liver or kidney dysfunction. Specific side effects of parathyroid transplantation are not listed but could involve complications from surgery.
PATH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have low calcium due to a neck surgery that affected my parathyroid glands.
Select...
I have low calcium due to underdeveloped parathyroid glands.
Select...
I have low calcium due to hypoparathyroidism and treatments haven't worked, affecting my daily life.
Select...
I am between 18 and 80 years old.
PATH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post-operatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-operatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Calcium supplementation
Parathyroid transplant function
Secondary outcome measures
Immunosuppression-related adverse events
Serum calcium level
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,588 Previous Clinical Trials
2,280,307 Total Patients Enrolled
Brenessa Lindeman, MD, MEHPPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic or highly sensitive to certain medications that can weaken the immune system.I rely on a nursing home or long-term care for my daily needs.I have low calcium due to a neck surgery that affected my parathyroid glands.I quit smoking more than 3 months ago.I have not had a serious infection in the last 3 months.I have tested positive for HIV, hepatitis B, hepatitis C, or HTLV-1.I have low calcium due to underdeveloped parathyroid glands.I have major difficulties with daily activities or thinking clearly and do not have someone to help me regularly.I have cancer, but it's not skin cancer.You have a problem with using drugs or drinking too much alcohol.I do not have severe heart, liver, kidney diseases, uncontrolled diabetes, or bleeding disorders.I have low calcium due to hypoparathyroidism for over a year.I have severe osteoporosis.You don't have enough resources to support the care you need after the transplant.You have a history of not following your doctor's instructions for taking medicine.You have documented issues with alcoholism, drug abuse, or behavioral disorders.I have low calcium due to hypoparathyroidism and treatments haven't worked, affecting my daily life.I am between 18 and 80 years old.You must live in the Birmingham area for the whole trial.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many subjects are being examined in this research project?
"Affirmative. Clinicaltrials.gov indicates that this trial was originally published on February 9th 2022 and has been updated recently on March 8th 2022, with the aim of recruiting 5 patients from a single medical centre."
Answered by AI
Is there still space available for participants in this clinical experiment?
"This clinical trial, which was initially uploaded on February 9th 2022, is currently open for patient enrollment. Per the data hosted on clinicaltrials.gov, it has been recently updated on March 8th 2022."
Answered by AI
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