Hyperparathyroidism; Secondary, RenalNCT04523974
Preemptive and Precise Intervention for CKD-SHPT
An observational study of Hyperparathyroidism; Secondary, Renal, run by Shanghai Zhongshan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperparathyroidism; Secondary, Renal
- What is being tested?
- Preemptive Surgical Intervention and Precise Efficacy Evaluation of CKD-SHPT
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Hyperparathyroidism; Secondary, Renal
- Being tested
- Preemptive Surgical Intervention and Precise Efficacy Evaluation of CKD-SHPT
- Medical subject headings
- Hyperparathyroidism, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preemptive Surgical Intervention and Precise Efficacy Evaluation of CKD-SHPTProcedure or surgery
- Preemptive surgical intervention for CKD-SHPT patients with poor calcium and phosphorus metabolism controlled by drugs;
- Rapid immunoreactive parathyroid hormone detection technology during peri-operative period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Preemptive Surgical Intervention and Precise Efficacy Evaluation of CKD-SHPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: October 2020 to September 2022
Secondary outcomes (7)
short-term and long-term mortality
The all-cause mortality rate and cardiovascular and cerebrovascular mortality rate during hospitalization, by Day 60, Day 180 and 1 year during follow-up.
Measured: October 2020 to September 2022
short-term and long-term bone metabolism
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.
Measured: October 2020 to September 2022
Medical Outcomes Short-Form Health Survey (SF36) Scale
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.
Measured: October 2020 to September 2022
cardiovascular function
The left ventricular ejection fraction (%, obtained by echocardiography) during hospitalization, by Day 180 and 1 year during medical visits.
Measured: October 2020 to September 2022
inpatient days
Length of hospitalization, according the electronic medical records.
Measured: October 2020 to September 2022
hospitalization costs
Cost of hospitalization, according the electronic medical records.
Measured: October 2020 to September 2022
adverse events associated with metabolic bone disease
e.g. fall down, bone fracture during follow-ups, through medical visits and telephone follow-ups.
Measured: October 2020 to September 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperparathyroidism; Secondary, RenalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Shen, Shanghai Zhongshan Hospital
- Investigators
- Bo Shen, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523974
- Sponsor's protocol ID
- PP-CKD-SHPT
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2020
- Last updated
- 24 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Surgical Intervention and Precise Efficacy Evaluation for Hyperparathyroidism Secondary to Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04523974
- Acronym / sponsor ID
- PP-CKD-SHPT
- Conditions
- Hyperparathyroidism; Secondary, Renal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preemptive and Precise Intervention | – | Procedure: Preemptive Surgical Intervention and Precise Efficacy Evaluation of CKD-SHPTPreemptive 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preemptive Surgical Intervention and Precise Efficacy Evaluation of CKD-SHPT1. 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. | Procedure or surgery | Preemptive and Precise Intervention |
Primary outcome
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.
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.
7 secondary outcomes
short-term and long-term mortality
Time frame: October 2020 to September 2022
short-term and long-term bone metabolism
Time frame: October 2020 to September 2022
Medical Outcomes Short-Form Health Survey (SF36) Scale
Time frame: October 2020 to September 2022
cardiovascular function
Time frame: October 2020 to September 2022
inpatient days
Time frame: October 2020 to September 2022
hospitalization costs
Time frame: October 2020 to September 2022
adverse events associated with metabolic bone disease
Time frame: October 2020 to September 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Shen, MD principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperparathyroidism; Secondary, Renal, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Shen, MD (+86 13564608233, shen.bo@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of preemptive surgical intervention (time frame: October 2020 to September 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020; AzTrials last refreshed its copy on 27 Oct 2026.