Clinical trial NCT04523974: Preemptive and Precise Intervention for CKD-SHPT
Official title: Preemptive Surgical Intervention and Precise Efficacy Evaluation for Hyperparathyroidism Secondary to Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperparathyroidism; Secondary, Renal
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion Criteria:

* 1) Chronic Kidney Disease Stage 3-5d patients aged ≥18 years;
* 2) The diagnosis is consistent with CKD-metabolic bone disease and SHPT after evaluation by a kidney specialist;
* 3) Sustained blood immunoreactive parathyroid hormone level of \> 300ng/ml, and had received drug treatment;
* 4) Persistent hypercalcemia and/or hyperphosphatemia that is not responding to medication;
* 5) Imaging suggested evidence of at least one parathyroid nodular hyperplasia;
* 6) Signed the informed consent.

Exclusion Criteria:

* 1) Age \<18 years old;
* 2) Patients with dialysis duration \< 3 months, or with other unstable dialysis state;
* 3) Kidney transplant patients;
* 4) Who is considered inappropriate to participate in this study after evaluation by the supervising physician.

Primary outcomes:
measure: Safety of preemptive surgical intervention
timeFrame: October 2020 to September 2022
measure: Efficacy of preemptive surgical intervention
timeFrame: October 2020 to September 2022
Secondary outcomes:
measure: short-term and long-term mortality
timeFrame: October 2020 to September 2022
measure: short-term and long-term bone metabolism
timeFrame: October 2020 to September 2022
measure: Medical Outcomes Short-Form Health Survey (SF36) Scale
timeFrame: October 2020 to September 2022
measure: cardiovascular function
timeFrame: October 2020 to September 2022
measure: inpatient days
timeFrame: October 2020 to September 2022
measure: hospitalization costs
timeFrame: October 2020 to September 2022
measure: adverse events associated with metabolic bone disease
timeFrame: October 2020 to September 2022
Other outcomes:
Locations:
Study officials:
affiliation: Fudan University
name: Bo Shen, MD
role: PRINCIPAL_INVESTIGATOR
References: