Preemptive and Precise Intervention for CKD-SHPT
Preemptive Surgical Intervention and Precise Efficacy Evaluation for Hyperparathyroidism Secondary to Chronic Kidney Disease
1 other identifier
observational
50
0 countries
N/A
Brief Summary
Through multi-center randomized controlled trial studies on preemptive surgical intervention in patients with chronic kidney disease (CKD) - secondary hyperparathyroidism (SHPT), to precisely evaluate the safety and effectiveness during perioperative period, and the long-term outcomes by 1-year follow-up. The follow-ups include the evaluation of the overall quality of life, calcium and phosphorus metabolism, hyperparathyroidism level, vitamin D metabolism, bone mineral density, soft tissue and vascular calcification.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2020
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2020
CompletedFirst Posted
Study publicly available on registry
August 24, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedAugust 24, 2020
August 1, 2020
2 years
August 17, 2020
August 19, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Safety of preemptive surgical intervention
The rate of post operative complications(including bleeding, infection, adjacent tissue injury) of early precise parathyroidectomy surgery in patients with CKD-SHPT, according to the electronic medical records of the hospital.
October 2020 to September 2022
Efficacy of preemptive surgical intervention
The rate of relapse of hyperparathyroidism after parathyroidectomy, according to the immunoreactive parathyroid hormone concentration.
October 2020 to September 2022
Secondary Outcomes (7)
short-term and long-term mortality
October 2020 to September 2022
short-term and long-term bone metabolism
October 2020 to September 2022
Medical Outcomes Short-Form Health Survey (SF36) Scale
October 2020 to September 2022
cardiovascular function
October 2020 to September 2022
inpatient days
October 2020 to September 2022
- +2 more secondary outcomes
Study Arms (1)
Preemptive and Precise Intervention
Preemptive surgical intervention will be performed on enrolled CKD-SHPT patients. Safety and efficacy of this intervention will be evaluated during peri-operative period, and long-term outcomes will be analyzed during 1-year follow-up.
Interventions
1. Preemptive surgical intervention for CKD-SHPT patients with poor calcium and phosphorus metabolism controlled by drugs; 2. Rapid immunoreactive parathyroid hormone detection technology during peri-operative period.
Eligibility Criteria
CKD 3-5d patients with the diagnosis of CKD-metabolic bone disease and SHPT, with sustained blood immunoreactive parathyroid hormone level of \> 300ng/ml, and persistent hypercalcemia and/or hyperphosphatemia, which are not responding to medication.
You may qualify if:
- \) Chronic Kidney Disease Stage 3-5d patients aged ≥18 years;
- \) The diagnosis is consistent with CKD-metabolic bone disease and SHPT after evaluation by a kidney specialist;
- \) Sustained blood immunoreactive parathyroid hormone level of \> 300ng/ml, and had received drug treatment;
- \) Persistent hypercalcemia and/or hyperphosphatemia that is not responding to medication;
- \) Imaging suggested evidence of at least one parathyroid nodular hyperplasia;
- \) Signed the informed consent.
You may not qualify if:
- \) Age \<18 years old;
- \) Patients with dialysis duration \< 3 months, or with other unstable dialysis state;
- \) Kidney transplant patients;
- \) Who is considered inappropriate to participate in this study after evaluation by the supervising physician.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
blood samples will be collected to evaluate the level of immunoreactive parathyroid hormone, 25(OH)Vitamin D, calcium, phosphate, alkaline phosphatase and biomarker series of osteogenic collagen metabolism and transformation.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bo Shen, MD
Fudan University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
August 17, 2020
First Posted
August 24, 2020
Study Start
October 1, 2020
Primary Completion
September 30, 2022
Study Completion
December 31, 2022
Last Updated
August 24, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share