Parathyroidectomy After Kidney Transplantation

NCT07415421 | Recruiting

• 2 other identifiers: 1-10-72-137-25NNF22SA0079901
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to clarify whether surgical treatment of persistent hyperparathyroidism after kidney transplantation offers clinically meaningful benefits compared with a conservative treatment strategy. Kidney transplant recipients (\>6 mo after transplantation) with persistent hyperparathyroidism (elevated PTH and either hypercalcemia or hypophosphatemia) will be randomized in a 1:1 ratio to either subtotal parathyroidectomy or conservative management according to standard clinical practice. The study is conducted as an open-label, randomized controlled pilot trial with a 12-month follow-up period. Outcomes include bone density, physical function, quality of life and symptom burden.

Conditions

Hyperparathyroidism; Kidney Transplantation Recipients

Keywords

Persistent hyperparathyroidism; Kidney transplant recipients; Parathyroidectomy; Bone mineral density; Muscle function; Quality of life; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in bone mineral density (BMD) at the total hip

  Bone mineral density (BMD) at the total hip will be measured using dual-energy X-ray absorptiometry (DXA) according to standardized procedures. Measurements will be performed at baseline and after 12 months. The primary outcome is the change in bone mineral density from baseline to 12 months.

  From baseline to end of study at 12 months

Secondary Outcomes (16)

• Changes in cortical and trabecular bone microarchitecture

  From baseline to end of study at 12 months

• Mineral metabolism: Change in plasma parathyroid hormone (PTH)

  From baseline to end of study at 12 months

• Mineral metabolism: Changes in serum ionized calcium and phosphate

  From baseline to end of study at 12 months

• Mineral metabolism: Change in plasma fibroblast growth factor 23 (FGF23)

  From baseline to end of study at 12 months

• Bone turnover marker: Change in bone-specific alkaline phosphatase (BALP)

  From baseline to end of study at 12 months

Study Arms (2)

Surgery group

EXPERIMENTAL

Participants assigned to this arm will undergo subtotal parathyroidectomy performed according to standard surgical practice. The procedure involves removal of the majority of parathyroid tissue with preservation of a small remnant. Intraoperative parathyroid hormone (PTH) measurements will be used to guide the extent of resection, in accordance with standard surgical principles. Surgery will be performed by experienced ear, nose and throat (ENT) surgeons. Participants will receive standard perioperative care and postoperative follow-up.

Procedure: Subtotal Parathyroidectomy

Control group

ACTIVE COMPARATOR

Participants assigned to this arm will receive conservative management according to standard clinical practice. This includes regular clinical follow-up and biochemical monitoring of calcium, phosphate, and parathyroid hormone levels. Medical treatment, such as calcium or vitamin D supplementation and/or calcimimetic therapy, may be initiated or adjusted at the discretion of the treating physician. No parathyroid surgery will be performed during the 12-month study period.

Other: Conservative Management

Interventions

Subtotal Parathyroidectomy PROCEDURE

Subtotal parathyroidectomy performed according to standard surgical practice. The procedure involves removal of the majority of parathyroid tissue with preservation of a small remnant. Intraoperative parathyroid hormone (PTH) measurements are used to guide the extent of resection. Standard perioperative care and postoperative follow-up are provided.

Surgery group

Conservative Management OTHER

Conservative management according to standard clinical practice, including regular clinical follow-up and biochemical monitoring of calcium, phosphate, and parathyroid hormone levels. Medical treatment, such as calcium or vitamin D supplementation and/or calcimimetic therapy, may be initiated or adjusted based on clinical judgment.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years and legally competent and able to understand spoken and written Danish
• Kidney transplantation ≥ 6 months prior (no upper limit of time after transplantation)
• Stable kidney graft function, defined as estimated GFR ≥ 30 ml/min/1.73m3
• On two consecutive biochemical measurements: PTH ≥1.5 times normal limit of assay and ionized calcium ≥1.35 mmol/L or albumin-corrected calcium ≥2.70 mmol/L or phosphate ≤0.50 mmol/L

You may not qualify if:

• Inability to provide written, informed consent
• Current anti-resorptive therapy (bisphosphonate, denosumab)
• Current bone anabolic therapy (teriparatide, romosozumab)
• Previous surgical parathyroidectomy
• Not considered fit for surgery (including pregnancy)
• Ionized calcium ≥1.50 mmol/L or albumin-corrected calcium ≥3.00 mmol/L despite discontinuation of calcium supplements.

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University of Aarhus: collaborator

Study Sites (1)

Departement of Nephrology, Aarhus University hospital

Aarhus, Central Jutland, 8200, Denmark

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Hyperparathyroidism

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Hanne S Jørgensen, MD, PhD

  Department of Nephrology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanne S Jørgensen, MD, PhD

CONTACT

+45 51 41 35 41; hsjorgensen@clin.au.dk

Amal Derai, MD

CONTACT

+45 51 36 03 80; amader@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 17, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning after publication of the primary study results and available until December 2035.
• Access Criteria: De-identified (pseudo-anonymized) individual participant data and supporting documents will be made available to qualified researchers upon reasonable request. Requests must include a methodologically sound research proposal. Access will be subject to approval by the principal investigator and relevant institutional authorities. Data sharing will require a data transfer agreement in accordance with the Danish Data Protection Act and the General Data Protection Regulation (GDPR), including Chapter V concerning transfers to third countries. Data will be shared in a secure manner and solely for research purposes.

Locations

DK (1)