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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: Preemptive Surgical Intervention and Precise Efficacy Evaluation of CKD-SHPT
  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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Zhongshan Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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