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NCT Number: NCT01178450

Parathyroidectomy vs Cinacalcet in the Treatment of Secondary Hyperparathyroidism Post Renal Transplantation

The hypothesis of this study is that subtotal parathyroidectomy using minimally invasive surgery is superior to cinacalcet for the treatment of persistent secondary hyperparathyroidism (HPT) post renal transplant, with minimal morbidity and significantly reduces the cost of treatment post transplant.

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Key information

Conditions

Secondary Hyperparathyroidism Calcium Metabolism Disorders Endocrine System Diseases Hypercalcemia Hyperparathyroidism Hyperparathyroidism, Secondary Metabolic Diseases Nutritional and Metabolic Diseases Parathyroid Diseases Water-Electrolyte Imbalance

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinic de Barcelona, Barcelona, Spain

Loading trial locations.

About this study

Persistent hyperparathyroidism (HPT) with hypercalcemia is prevalent after transplant (affects up to 25% of patients) and negatively affects graft and patient outcome. The subtotal parathyroidectomy is the standard treatment, although currently has been replaced by the calcimimetic cinacalcet. Several studies guarantee that cinacalcet is effective in controlling hypercalcemia derived of persistent HPT after renal transplantation. However, maintenance treatment is need because hypercalcemia increases quickly after treatment is stopped. This fact makes increase a lot the cost of transplantation in these patients.

The hypothesis of this study is that subtotal parathyroidectomy by minimally invasive surgery is superior to cinacalcet for treatment of persistent secondary HPT post renal transplant, with minimal morbidity and significantly reduces the cost of treatment after transplantation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Functioning renal transplant, GFR ≥ 30 ml / min
  • Time post-transplant> 6 months
  • PTHi>15pmol/L
  • Calcium ≥2.63 mmol/L con phosphatemia ≤1.2 mmol/L
  • Cervical scintigraphy
  • Signed informed consent

Exclusion criteria

  • Contraindication to surgery

Treatment and study plan

Subtotal Parathyroidectomy

Procedure

The procedure of choice is subtotal parathyroidectomy if the intraoperative biopsy confirms multiglandular disease and at least 3 glands are removed leaving a remanent of one normal gland

Other names: Parathyroidectomy

Cinacalcet

Drug

Cinacalcet is initiated at a dose of 30 mg per day PO, adjusting the dose monthly (up to 90 mg per day PO) to achieve normocalcemia

Primary outcomes

  1. Change in blood calcium levels

    Time frame: 12 months

    Change from baseline in blood calcium levels at 12 months.

Secondary outcomes

  1. Change in parathyrin blood levels

    Time frame: 12 months

    Change from baseline in parathyrin blood levels at 12 months.

  2. Patient and graft survival

    Time frame: 12 months

    Patient and graft survival between inclusion and month 12.

  3. Economic evaluation of interventions measured by money spend in it.

    Time frame: 12 months

    Comparison of economic evaluations of both interventions between inclusion and month 12.

  4. Estimated glomerular filtration rate.

    Time frame: 12 months

    Change from baseline in glomerular filtration rate at 12 months.

  5. Change in blood calcium levels

    Time frame: 3 months

    Change from baseline in blood calcium levels at 3 months.

  6. Change in blood calcium levels

    Time frame: 6 months

    Change from baseline in blood calcium levels at 6 months.

  7. Change in parathyrin blood levels

    Time frame: 3 months

    Change from baseline parathyrin blood levels at 3 months.

  8. Change in parathyrin blood levels

    Time frame: 6 months

    Change from baseline parathyrin blood levels at 6 months.

Sponsors and collaborators

Lead sponsor

Josep m Cruzado

Other

Registry information

Official study title

A Prospective, Randomized Trial to Compare Subtotal Parathyroidectomy Versus Cinacalcet in the Treatment of Persistent Secondary Hyperparathyroidism Post Renal Transplantation

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 10, 2010
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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