NCT01178450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 10, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

4.7 years

First QC Date

April 19, 2010

Last Update Submit

April 27, 2015

Conditions

Secondary Hyperparathyroidism

Keywords

Renal transplantHypercalcemia

Outcome Measures

Primary Outcomes (1)

  • Change in blood calcium levels

    Change from baseline in blood calcium levels at 12 months.

    12 months

Secondary Outcomes (8)

  • Change in parathyrin blood levels

    12 months

  • Patient and graft survival

    12 months

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

    12 months

  • Estimated glomerular filtration rate.

    12 months

  • Change in blood calcium levels

    3 months

  • +3 more secondary outcomes

Study Arms (2)

Subtotal parathyroidectomy

ACTIVE COMPARATOR

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

Cinacalcet

EXPERIMENTAL

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

Interventions

Subtotal parathyroidectomyPROCEDURE

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

Also known as: Parathyroidectomy
Subtotal parathyroidectomy
CinacalcetDRUG

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

Cinacalcet

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindication to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelone, 08907, Spain

Location

MeSH Terms

Conditions

Hyperparathyroidism, SecondaryHypercalcemia

Interventions

ParathyroidectomyCinacalcet

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, OperativeNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Josep M Cruzado, MD

    Nephrology Department. Hospital Universitari de Bellvitge

    STUDY CHAIR

  • Pablo Moreno, MD

    Surgery Department. Hospital Universitari de Bellvitge

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Nephrologist

Study Record Dates

First Submitted

April 19, 2010

First Posted

August 10, 2010

Study Start

January 1, 2010

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

ES(2)