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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Josep M Cruzado, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01178450
First received: April 19, 2010
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Secondary Hyperparathyroidism
Procedure: Subtotal parathyroidectomy
Drug: Cinacalcet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial to Compare Subtotal Parathyroidectomy Versus Cinacalcet in the Treatment of Persistent Secondary Hyperparathyroidism Post Renal Transplantation

Resource links provided by NLM:


Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • Change in blood calcium levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline in blood calcium levels at 12 months.


Secondary Outcome Measures:
  • Change in parathyrin blood levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline in parathyrin blood levels at 12 months.

  • Patient and graft survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Patient and graft survival between inclusion and month 12.

  • Economic evaluation of interventions measured by money spend in it. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Compararison of economic evaluations of both interventions between inclusion and month 12.

  • Estimated glomerular filtration rate measured by MDRD and Cockcroft- Gault formula. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Change from baseline in glomerular filtration rate at 12 months.

  • Change in blood calcium levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change from baseline in blood calcium levels at 3 months.

  • Change in blood calcium levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change from baseline in blood calcium levels at 6 months.

  • Change in parathyrin blood levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change from baseline parathyrin blood levels at 3 months.

  • Change in parathyrin blood levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change from baseline parathyrin blood levels at 6 months.


Estimated Enrollment: 30
Study Start Date: January 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Subtotal parathyroidectomy
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
Procedure: Subtotal parathyroidectomy
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 Name: Parathyroidectomy
Experimental: Cinacalcet
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
Drug: Cinacalcet
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
Other Name: CINACALCET

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178450

Locations
Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelone, Spain, 08907
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Josep M Cruzado
Investigators
Study Chair: Josep M Cruzado, MD Nephrology Department. Hospital Universitari de Bellvitge
Study Chair: Pablo Moreno, MD Surgery Department. Hospital Universitari de Bellvitge
  More Information

No publications provided

Responsible Party: Josep M Cruzado, Nephrologist, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT01178450     History of Changes
Other Study ID Numbers: 01PTHi, 2008-007017-76
Study First Received: April 19, 2010
Last Updated: February 14, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari de Bellvitge:
Renal transplant
Hypercalcemia

Additional relevant MeSH terms:
Neoplasm Metastasis
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014