Comparing two surgical methods for treating secondary hyperparathyroidism
Official title: Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism
Run by The Second Hospital of Nanjing Medical University · NCT04922892 · Data updated 2026-11-12
This study is testing whether a surgery that includes transplanting parathyroid tissue works better than just removing the parathyroid glands alone for people with secondary hyperparathyroidism who are on long-term dialysis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | The Second Hospital of Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing) |
| Status | Recruiting |
| Started | June 1, 2021 |
| Main results expected | May 31, 2023 |
| Study ends | May 31, 2028 |
| Registry record updated | September 27, 2021 |
| Trial ID | NCT04922892 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with severe renal secondary hyperparathyroidism who are on long-term dialysis.
✕Probably not a fit
Patients with a history of diabetes, chronic inflammatory diseases, malignant tumors, kidney transplantation, neck surgery, alcohol or drug abuse, or those unable to cooperate may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial compares the long-term outcomes of total parathyroidectomy with autotransplantation (TPTX+AT) versus total parathyroidectomy alone (TPTX) in patients with secondary hyperparathyroidism who are on long-term dialysis. It is a randomized controlled pilot trial involving 200 patients, aiming to assess the rates of recurrent disease over a 5-year follow-up period. Key metrics evaluated include parathyroid hormone and calcium levels, as well as rates of recurrent or persistent hyperparathyroidism, reoperations, morbidity, and mortality.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective surgical approach for managing secondary hyperparathyroidism in dialysis patients.
How similar studies have gone: Previous studies have explored similar surgical interventions, but this specific comparison of TPTX versus TPTX+AT in this patient population is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Severe renal secondary hyperparathyroidism Exclusion Criteria: Patients with diabetes a history of chronic inflammatory disease a history of malignant tumor a history of kidney transplantation a history of neck surgery a history of alcohol abuse a history of drug abuse inability to cooperate with the participants refusal to participate in the study
Where it's running
-
NanjingMU
Nanjing, China Recruiting
Study contacts
- Study coordinator: Mingxia XIONG, Ph.D
- Email: xiongmingxia@njmu.edu.cn
- Phone: 13951880995
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
CTAP101 extended-release capsules in kids with CKD and vitamin D insufficiency
A daily bedtime dose of CTAP101 is being tested in children with CKD stages 3–4 and secondary hyperparathyroidism to see how the drug moves in the body, how it affects the body, and whether it is safe and tolerable.
-
Evaluating the effects of Pacitol Inj. on patients with chronic kidney disease and secondary hyperparathyroidism
This study is testing if a new injection called Pacitol can help people with severe kidney disease and high parathyroid hormone levels feel better while they are on dialysis.
-
Using microRNA to improve treatment for renal osteodystrophy
This study is testing if a new method using microRNA can help doctors better understand bone health in people with chronic kidney disease and improve their treatment for renal osteodystrophy.
-
Treatment of secondary hyperparathyroidism in children on hemodialysis
This study tests if a new medication called etelcalcetide can help children on hemodialysis lower their parathyroid hormone levels safely.
-
Etelcalcetide treatment for children with kidney disease and high parathyroid hormone levels
This study is testing if a new treatment called Etelcalcetide can help children with kidney disease and high parathyroid hormone levels feel better and avoid serious health problems.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.