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Secondary HyperparathyroidismPhase 4NCT01178450

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

A Phase 4 study testing Subtotal parathyroidectomy and Cinacalcet in people with Secondary Hyperparathyroidism, run by Josep M Cruzado at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Secondary Hyperparathyroidism
What is being tested?
Subtotal parathyroidectomy and Cinacalcet
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesSpain
Study dates
Jan 2010to Sep 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Contraindication to surgery

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Hospital Clinic de Barcelona

    Barcelona, Barcelona, 08036

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelone, 08907

Other trials in Spain

About this study

Official title: A Prospective, Randomized Trial to Compare Subtotal Parathyroidectomy Versus Cinacalcet in the Treatment of Persistent 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.

Read the 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.

Being tested
Subtotal parathyroidectomy, Cinacalcet
Keywords
Renal transplant, Hypercalcemia
Medical subject headings
Hyperparathyroidism, Secondary, Hypercalcemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subtotal parathyroidectomyProcedure or surgery

    Also called 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

  • 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

Study groups in NCT01178450
Study groupRoleWhat they receive
Subtotal parathyroidectomyActive comparatorThe 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
Receives: Procedure: Subtotal parathyroidectomy
CinacalcetExperimentalCinacalcet 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
Receives: Drug: Cinacalcet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in blood calcium levels

    Change from baseline in blood calcium levels at 12 months.

    Measured: 12 months

Secondary outcomes (8)

  1. Change in parathyrin blood levels

    Change from baseline in parathyrin blood levels at 12 months.

    Measured: 12 months

  2. Patient and graft survival

    Patient and graft survival between inclusion and month 12.

    Measured: 12 months

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

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

    Measured: 12 months

  4. Estimated glomerular filtration rate.

    Change from baseline in glomerular filtration rate at 12 months.

    Measured: 12 months

  5. Change in blood calcium levels

    Change from baseline in blood calcium levels at 3 months.

    Measured: 3 months

  6. Change in blood calcium levels

    Change from baseline in blood calcium levels at 6 months.

    Measured: 6 months

  7. Change in parathyrin blood levels

    Change from baseline parathyrin blood levels at 3 months.

    Measured: 3 months

  8. Change in parathyrin blood levels

    Change from baseline parathyrin blood levels at 6 months.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01178450
Sponsor's protocol ID
01PTHi
Other IDs
2008-007017-76, 2008
Status last verified
Apr 2015
First submitted
19 Apr 2010
Last updated
28 Apr 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Subtotal parathyroidectomy and Cinacalcet in people with Secondary Hyperparathyroidism, run by Josep M Cruzado at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in blood calcium levels (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01178450.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.

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