Preemptive and Precise Intervention for CKD-SHPT

NCT ID: NCT04523974

Last Updated: 2020-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-12-31

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.

Conditions

Hyperparathyroidism; Secondary, Renal

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Preemptive Surgical Intervention and Precise Efficacy Evaluation of CKD-SHPT

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bo Shen

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bo Shen, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Central Contacts

Bo Shen, MD

Role: CONTACT

shen.bo@zs-hospital.sh.cn

+86 13564608233

Other Identifiers

PP-CKD-SHPT

Identifier Type: -

Identifier Source: org_study_id