- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04523974
Preemptive and Precise Intervention for CKD-SHPT
August 19, 2020 updated by: Bo Shen, Shanghai Zhongshan Hospital
Preemptive Surgical Intervention and Precise Efficacy Evaluation for Hyperparathyroidism Secondary to Chronic Kidney Disease
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
50
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of preemptive surgical intervention
Time Frame: October 2020 to September 2022
|
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
Time Frame: October 2020 to September 2022
|
The rate of relapse of hyperparathyroidism after parathyroidectomy, according to the immunoreactive parathyroid hormone concentration.
|
October 2020 to September 2022
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
short-term and long-term mortality
Time Frame: October 2020 to September 2022
|
The all-cause mortality rate and cardiovascular and cerebrovascular mortality rate during hospitalization, by Day 60, Day 180 and 1 year during follow-up.
|
October 2020 to September 2022
|
short-term and long-term bone metabolism
Time Frame: October 2020 to September 2022
|
The level of immunoreactive parathyroid hormone, 25(OH)-vitamin D, calcium, phosphate, alkaline phosphatase and biomarker series of bone metabolism during hospitalization, by Day 60, Day 180 and 1 year.
|
October 2020 to September 2022
|
Medical Outcomes Short-Form Health Survey (SF36) Scale
Time Frame: October 2020 to September 2022
|
Medical Outcomes Short-Form Health Survey (SF36) scale on quality of life during hospitalization, by Day 60, Day 180 and 1 year during follow-ups.
The minimum value is 0, and the maximum value is 100, and higher scores mean a better outcome.
|
October 2020 to September 2022
|
cardiovascular function
Time Frame: October 2020 to September 2022
|
The left ventricular ejection fraction (%, obtained by echocardiography) during hospitalization, by Day 180 and 1 year during medical visits.
|
October 2020 to September 2022
|
inpatient days
Time Frame: October 2020 to September 2022
|
Length of hospitalization, according the electronic medical records.
|
October 2020 to September 2022
|
hospitalization costs
Time Frame: October 2020 to September 2022
|
Cost of hospitalization, according the electronic medical records.
|
October 2020 to September 2022
|
adverse events associated with metabolic bone disease
Time Frame: October 2020 to September 2022
|
e.g.
fall down, bone fracture during follow-ups, through medical visits and telephone follow-ups.
|
October 2020 to September 2022
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bo Shen, MD, Fudan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2020
Primary Completion (Anticipated)
September 30, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
August 17, 2020
First Submitted That Met QC Criteria
August 19, 2020
First Posted (Actual)
August 24, 2020
Study Record Updates
Last Update Posted (Actual)
August 24, 2020
Last Update Submitted That Met QC Criteria
August 19, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PP-CKD-SHPT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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