Preemptive and Precise Intervention for CKD-SHPT

Fudan University

Status: Unknown

Conditions: Hyperparathyroidism; Secondary, Renal

Treatments: Procedure: Preemptive Surgical Intervention and Precise Efficacy Evaluation of CKD-SHPT

Study type: Observational

Funder types: Other

Identifiers

NCT04523974

PP-CKD-SHPT

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Preemptive and Precise Intervention

Description:

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.

Treatment:

Procedure: Preemptive Surgical Intervention and Precise Efficacy Evaluation of CKD-SHPT