NCT04523974|Unknown
Preemptive and Precise Intervention for CKD-SHPT
Preemptive Surgical Intervention and Precise Efficacy Evaluation for Hyperparathyroidism Secondary to Chronic Kidney Disease
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Preemptive Surgical Intervention and Precise Efficacy Evaluation for Hyperparathyroidism Secondary to Chronic Kidney Disease
Sponsor study identifier
observational
50
0 countries
N/A
Study Start
October 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 17, 2020
Actual (reported)August 24, 2020
Actual (reported)October 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
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.
Bo Shen, MD
Fudan University
First Submitted
August 17, 2020
First Posted
August 24, 2020
Study Start
October 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2022
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 24, 2020
Record last verified: 2020-08
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Source: ClinicalTrials.gov.
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