HyperparathyroidismPhase 4NCT01143987
Cincalcet and Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism
A Phase 4 study testing Cinacalcet in people with Hyperparathyroidism and Arterial Stiffness, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Active parathyroid glands among renal dialysis patients contribute to calcified and hardened blood vessels. Such damage to the blood vessels, in turn, takes a significant toll in terms of cardiovascular disease. Calcimimetics has been suggested to lower the risk of vascular calcification. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperparathyroidism, Arterial Stiffness
- What is being tested?
- Cinacalcet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2010to Feb 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- plasma parathyroid hormone level of at least 300 pg/ml (31.8 pmol/L)
- aged 18 or older on peritoneal dialysis for at least three months
- willingness to give written consent and comply with the study protocol
Who cannot join
- evidence of cancer, active infection or diseases with limited life expectancy
- diseases known to cause hypercalcaemia
- adjusted serum calcium level below 2.1 mmol/L (8.4 mg/dL) after correction for albumin
- participation in another interventional study within last 30 days of randomization
- history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the study procedures
- patients receiving drugs with a narrow therapeutic index and metabolized by cytochrome P-450 2D6 (which is inhibited by cinacalcet): flecainide, thioridazine and most tricyclic antidepressants
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Prince of Wales Hospital, Chinese University of Hong Kong
Shatin, New Territories, SAR
About this study
Official title: Effect of Cinacalcet Treatment on Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism
Active parathyroid glands among renal dialysis patients contribute to calcified and hardened blood vessels. Such damage to the blood vessels, in turn, takes a significant toll in terms of cardiovascular disease. Calcimimetics has been suggested to lower the risk of vascular calcification. Role of cinacalcet was demonstrated in animal model but human data are lacking. The investigators designed an open label pilot study to evaluate the effect of cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary hyperparathyroidism despite standard treatment. The primary outcome is the aortic pulse wave velocity at 26 and 52 months after cinacalcet treatment.
Read the detailed description
Mineral metabolism disturbance and hyperparathyroidism contribute to arterial stiffness and vascular calcification. The vascular damage, in turn, contributes to significant cardiovascular morbidity and mortality of end-stage renal disease patients. Calcimimetics has been suggested to lower the risk of vascular calcification. Role of cinacalcet was demonstrated in animal model but human data are lacking. We design an open label pilot study to evaluate the effect of cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary hyperparathyroidism despite standard treatment. The primary outcome is the aortic pulse wave velocity at 26 and 52 months after cinacalcet treatment.
- Conditions
- Hyperparathyroidism, Arterial Stiffness
- Being tested
- Cinacalcet
- Keywords
- hyperparathyroidism, pulse wave velocity, end-stage renal disease, arterial stiffness
- Medical subject headings
- Hyperparathyroidism, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinacalcetDrug
Also called Sensipar
starting with 25 mg daily dose with titration, maximum dose 100 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Cinacalcet | Experimental | Oral cinacalcet Receives: Drug: Cinacalcet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic pulse wave velocity after the cinacalcet treatment
as before
Measured: change in aortic pulse wave velocity at 52 weeks from baseline
Secondary outcomes (5)
Percent change in the values for parathyroid hormone levels
Blood samples will be stored before and after treatment with cinacalcet for further analysis.
Measured: within one year of treatment with cinacalcet
Change in calcium levels
as before
Measured: within one year of treatment with cinacalcet
Aortic pulse wave velocity after the cinacalcet treatment
as stated in the description of Primary Outcome Measure
Measured: change in aortic pulse wave velocity at 26 weeks from baseline
Change in phosphorus levels
as before
Measured: within one year of cinacalcet treatment
Change in calcium-phosphorus product
as before
Measured: within one year of cinacalcet treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chow Kai Ming, Chinese University of Hong Kong
- Investigators
- Kai Ming Chow, MBChB, Principal investigator, Chinese University of Hong Kong, Prince of Wales Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143987
- Sponsor's protocol ID
- CRE-2010.084-T
- Status last verified
- Nov 2013
- First submitted
- 10 Jun 2010
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Chow KM, Szeto CC, Kwan BC, Cheng PM, Pang WF, Leung CB, Li PK. Effect of cinacalcet treatment on vascular arterial stiffness among peritoneal dialysis patients with secondary hyperparathyroidism. Nephrology (Carlton). 2014 Jun;19(6):339-44. doi: 10.1111/nep.12223.
PubMed 24589316
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cinacalcet Treatment on Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT01143987
- Acronym / sponsor ID
- CRE-2010.084-T
- Conditions
- Hyperparathyroidism, Arterial Stiffness
- Keywords
- hyperparathyroidism, pulse wave velocity, end-stage renal disease, arterial stiffness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 Jun 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.
Active parathyroid glands among renal dialysis patients contribute to calcified and hardened blood vessels. Such damage to the blood vessels, in turn, takes a significant toll in terms of cardiovascular disease. Calcimimetics has been suggested to lower the risk of vascular calcification. Role of cinacalcet was demonstrated in animal model but human data are lacking. The investigators designed an open label pilot study to evaluate the effect of cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary hyperparathyroidism despite standard treatment. The primary outcome is the aortic pulse wave velocity at 26 and 52 months after cinacalcet treatment.
Detailed description
Mineral metabolism disturbance and hyperparathyroidism contribute to arterial stiffness and vascular calcification. The vascular damage, in turn, contributes to significant cardiovascular morbidity and mortality of end-stage renal disease patients. Calcimimetics has been suggested to lower the risk of vascular calcification. Role of cinacalcet was demonstrated in animal model but human data are lacking. We design an open label pilot study to evaluate the effect of cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary hyperparathyroidism despite standard treatment. The primary outcome is the aortic pulse wave velocity at 26 and 52 months after cinacalcet treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cinacalcet | Experimental | Drug: CinacalcetOral cinacalcet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- plasma parathyroid hormone level of at least 300 pg/ml (31.8 pmol/L)
- aged 18 or older on peritoneal dialysis for at least three months
- willingness to give written consent and comply with the study protocol
Key exclusion criteria (6 listed)
- evidence of cancer, active infection or diseases with limited life expectancy
- diseases known to cause hypercalcaemia
- adjusted serum calcium level below 2.1 mmol/L (8.4 mg/dL) after correction for albumin
- participation in another interventional study within last 30 days of randomization
- history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the study procedures
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 |
|---|---|---|
| CinacalcetAlso: Sensiparstarting with 25 mg daily dose with titration, maximum dose 100 mg daily | Drug | Cinacalcet |
Primary outcome
Aortic pulse wave velocity after the cinacalcet treatment
Time frame: change in aortic pulse wave velocity at 52 weeks from baseline
as before
5 secondary outcomes
Percent change in the values for parathyroid hormone levels
Time frame: within one year of treatment with cinacalcet
Change in calcium levels
Time frame: within one year of treatment with cinacalcet
Aortic pulse wave velocity after the cinacalcet treatment
Time frame: change in aortic pulse wave velocity at 26 weeks from baseline
Change in phosphorus levels
Time frame: within one year of cinacalcet treatment
Change in calcium-phosphorus product
Time frame: within one year of cinacalcet treatment
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 13 Nov 2013.
- Derived from this study: PubMed 24589316Chow KM, Szeto CC, Kwan BC, Cheng PM, Pang WF, Leung CB, Li PK. Effect of cinacalcet treatment on vascular arterial stiffness among peritoneal dialysis patients with secondary hyperparathyroidism. Nephrology (Carlton). 2014 Jun;19(6):339-44. doi: 10.1111/nep.12223.
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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.
Kai Ming Chow, MBChB principal investigator
Chinese University of Hong Kong, Prince of Wales Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cinacalcet in people with Hyperparathyroidism and Arterial Stiffness, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 6 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 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
Aortic pulse wave velocity after the cinacalcet treatment (time frame: change in aortic pulse wave velocity at 52 weeks from baseline). 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 NCT01143987, which also lists 1 linked publication.
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 13 Nov 2013.