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

Primary Purpose

Secondary Hyperparathyroidism

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Subtotal parathyroidectomy
Cinacalcet
Sponsored by
Josep M Cruzado
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Renal transplant, Hypercalcemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitari de Bellvitge
  • Hospital Clinic de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Subtotal parathyroidectomy

Cinacalcet

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in blood calcium levels
Change from baseline in blood calcium levels at 12 months.

Secondary Outcome Measures

Change in parathyrin blood levels
Change from baseline in parathyrin blood levels at 12 months.
Patient and graft survival
Patient and graft survival between inclusion and month 12.
Economic evaluation of interventions measured by money spend in it.
Comparison of economic evaluations of both interventions between inclusion and month 12.
Estimated glomerular filtration rate.
Change from baseline in glomerular filtration rate at 12 months.
Change in blood calcium levels
Change from baseline in blood calcium levels at 3 months.
Change in blood calcium levels
Change from baseline in blood calcium levels at 6 months.
Change in parathyrin blood levels
Change from baseline parathyrin blood levels at 3 months.
Change in parathyrin blood levels
Change from baseline parathyrin blood levels at 6 months.

Full Information

First Posted
April 19, 2010
Last Updated
April 27, 2015
Sponsor
Josep M Cruzado
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1. Study Identification

Unique Protocol Identification Number
NCT01178450
Brief Title
Parathyroidectomy vs Cinacalcet in the Treatment of Secondary Hyperparathyroidism Post Renal Transplantation
Official Title
A Prospective, Randomized Trial to Compare Subtotal Parathyroidectomy Versus Cinacalcet in the Treatment of Persistent Secondary Hyperparathyroidism Post Renal Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Josep M Cruzado

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism
Keywords
Renal transplant, Hypercalcemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subtotal parathyroidectomy
Arm Type
Active Comparator
Arm Description
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
Arm Title
Cinacalcet
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Subtotal parathyroidectomy
Other Intervention Name(s)
Parathyroidectomy
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Cinacalcet
Intervention Description
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 Outcome Measure Information:
Title
Change in blood calcium levels
Description
Change from baseline in blood calcium levels at 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in parathyrin blood levels
Description
Change from baseline in parathyrin blood levels at 12 months.
Time Frame
12 months
Title
Patient and graft survival
Description
Patient and graft survival between inclusion and month 12.
Time Frame
12 months
Title
Economic evaluation of interventions measured by money spend in it.
Description
Comparison of economic evaluations of both interventions between inclusion and month 12.
Time Frame
12 months
Title
Estimated glomerular filtration rate.
Description
Change from baseline in glomerular filtration rate at 12 months.
Time Frame
12 months
Title
Change in blood calcium levels
Description
Change from baseline in blood calcium levels at 3 months.
Time Frame
3 months
Title
Change in blood calcium levels
Description
Change from baseline in blood calcium levels at 6 months.
Time Frame
6 months
Title
Change in parathyrin blood levels
Description
Change from baseline parathyrin blood levels at 3 months.
Time Frame
3 months
Title
Change in parathyrin blood levels
Description
Change from baseline parathyrin blood levels at 6 months.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep M Cruzado, MD
Organizational Affiliation
Nephrology Department. Hospital Universitari de Bellvitge
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pablo Moreno, MD
Organizational Affiliation
Surgery Department. Hospital Universitari de Bellvitge
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelone
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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