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

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.
  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

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.

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

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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