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.
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
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.
- Conditions
- Secondary Hyperparathyroidism
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Cinacalcet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood calcium levels
Change from baseline in blood calcium levels at 12 months.
Measured: 12 months
Secondary outcomes (8)
Change in parathyrin blood levels
Change from baseline in parathyrin blood levels at 12 months.
Measured: 12 months
Patient and graft survival
Patient and graft survival between inclusion and month 12.
Measured: 12 months
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
Estimated glomerular filtration rate.
Change from baseline in glomerular filtration rate at 12 months.
Measured: 12 months
Change in blood calcium levels
Change from baseline in blood calcium levels at 3 months.
Measured: 3 months
Change in blood calcium levels
Change from baseline in blood calcium levels at 6 months.
Measured: 6 months
Change in parathyrin blood levels
Change from baseline parathyrin blood levels at 3 months.
Measured: 3 months
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.
- First posted10 Aug 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Josep M Cruzado
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Josep M Cruzado, Hospital Universitari de Bellvitge
- Investigators
- Josep M Cruzado, MD, Study chair, Nephrology Department. Hospital Universitari de BellvitgePablo Moreno, MD, Study chair, Surgery Department. Hospital Universitari de Bellvitge
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial to Compare Subtotal Parathyroidectomy Versus Cinacalcet in the Treatment of Persistent Secondary Hyperparathyroidism Post Renal Transplantation
- ClinicalTrials.gov ID
- NCT01178450
- Acronym / sponsor ID
- 01PTHi
- Conditions
- Secondary Hyperparathyroidism
- Keywords
- Renal transplant, Hypercalcemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Josep M CruzadoUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 10 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subtotal parathyroidectomy | Active comparator | Procedure: Subtotal parathyroidectomyThe 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 | Experimental | Drug: CinacalcetCinacalcet 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Contraindication to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subtotal parathyroidectomyAlso: ParathyroidectomyThe 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 or surgery | Subtotal parathyroidectomy |
| CinacalcetCinacalcet 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 |
Primary outcome
Change in blood calcium levels
Time frame: 12 months
Change from baseline in blood calcium levels at 12 months.
8 secondary outcomes
Change in parathyrin blood levels
Time frame: 12 months
Patient and graft survival
Time frame: 12 months
Economic evaluation of interventions measured by money spend in it.
Time frame: 12 months
Estimated glomerular filtration rate.
Time frame: 12 months
Change in blood calcium levels
Time frame: 3 months
Change in blood calcium levels
Time frame: 6 months
Change in parathyrin blood levels
Time frame: 3 months
Change in parathyrin blood levels
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep M Cruzado, MD study chair
Nephrology Department. Hospital Universitari de Bellvitge
Pablo Moreno, MD study chair
Surgery Department. Hospital Universitari de Bellvitge
2 sites in 1 country: see every site and its status.
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?
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.