Hyperparathyroidism, SecondaryPhase 4NCT02056730
The Study of Efficacy and Safety of REGPARA Drug in Dialysis Patients Have High Blood Levels of Parathyroid
A Phase 4 study testing calcium sensing receptor agonist in people with Hyperparathyroidism, Secondary, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The dialysis patient of chronic kidney disease and parathyroid hormone levels greater than or equal to 800 Pg per ml were divided into two groups by randomized 1:1, one group to receive medication and a control group that did not receive the medication. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperparathyroidism, Secondary
- What is being tested?
- calcium sensing receptor agonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2013to Feb 2015
- 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
- 1. The patient have age more equal 18 year on enrollment date. 2. The patient get the dialysis of 3 times per week 3. The parathyroid hormone level greater than or equal to 800 pg per mL during the screening 4.The calcium level in the blood is greater than or equal to 9 mg per dL.
Who cannot join
- The patient had parathyroid gland surgery.
- The patient have a history of seizures within 12 weeks before randomized.
- The patient is scheduled for surgery the kidney
- The patient will expected parathyroid gland surgery within 6 months
- The liver function have abnormalities, including SGOT, SGPT, more than two fold
- The patient had history received a drug of bisphosphonates group or expected to be received during the study.
- The patient had a history of cancer. Pregnant women. Lactating women. And with sepsis -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Study of Efficacy and Safety of Calcium Sensing Receptor in Chronic Dialysis Patients
The dialysis patient of chronic kidney disease and parathyroid hormone levels greater than or equal to 800 Pg per ml were divided into two groups by randomized 1:1, one group to receive medication and a control group that did not receive the medication. By group to receive in those taking 25 mg per day to get the default dose and the dose is adjusted according to the levels of calcium and parathyroid hormone. By adjusting the dose of 25 mg every 3 weeks for a period of 12 weeks, the drug is between 25-75 mg dose , with a maximum dose of not more than 100 mg per day (weeks 3, 6 , 9).
After a follow-up treatment in weeks 12, 24 and 36 with an blood,ultrasound test parathyroid glands , abdominal x-ray side . To evaluate the changes without the drug .Unless the track during treatment the patients with low blood calcium levels over 8.4 mg per dL . No dose adjustment . regpara while if blood calcium levels less than 7.5 mg per deciliter . Must be stop taking medication for patients in the control group will receive standard treatment . Which consisted of dose vitamin D sterol and parathyroid surgery . Unable to control the level of parathyroid hormone with vitamin D sterol.
While participating in the research are not allowed to adjust the amount of vitamin D sterol in the two groups . But the amount of dialysate calcium phosphate binders and can be adjusted as appropriate to healthcare is fine .
Read the detailed description
The renal impairment is caused FGF-23 resistance to the congestion of phosphate and stimulate the secretion of parathyroid hormone (PTH) from the parathyroid gland causes secondary hyperparathyroidism. They also found that high levels of FGF-23 is also a risk factor of vascular calcification.
The Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) is a disorder caused by renal impairment cause abnormalities occurring in the body. Can be summarized into three main parts as follows : 1) The disorders of minerals and hormones (laboratory abnormalities) such as hyperphosphatemia, secondary hyperparathyroidism. 2 ) The disorders of bone (bone abnormalities) , formerly known as renal osteodystrophy 3) The vascular calcification which results happened increase the risk of heart disease and stroke (cardiovascular disease) , broken bones (fractures) and death rate (mortality).
The secondary hyperparathyroidism. PTH secretion from parathyroid glands are more than normal and a major cause of the congestion of phosphate , reduced levels of 1,25-dihydroxyvitamin D [1,25 (OH) 2D] in the blood and a decrease in blood calcium levels decreased calcium levels in the blood is low. will result in a calcium (calcium sensing receptor or CaSR) on parathyroid glands make parathyroid cell signaling and increased PTH secretion .
That PTH increased continuously in the long run will cause the destruction of the bone called bone decay know "osteitis fibrosa". Some patients with a bone fracture. Important characteristics of osteitis fibrosa is an increase of bone destruction(osteoclastic bone resorption). In addition, the bone marrow may also be found associated with bone marrow fibrosis which causes anemia and did not respond to erythropoietin.
- Conditions
- Hyperparathyroidism, Secondary
- Being tested
- calcium sensing receptor agonist
- Keywords
- chronic hemodialysis patients, Hyperparathyroidism, Regpara, FGF 23
- Medical subject headings
- Hyperparathyroidism, Secondary, Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium sensing receptor agonistDrug
Also called Regpara
For the Regpara those taking 25 mg per day to get the default dose and the dose is adjusted according to the levels of calcium and parathyroid hormone. By adjusting the dose of 25 mg every 3 weeks for a period of 12 weeks, the drug is between 25-75 mg dose, with a maximum dose of not more than 100 mg per day (weeks 3, 6, 9).
| Study group | Role | What they receive |
|---|---|---|
| Regpara | Experimental | calcium sensing receptor agonist Receives: Drug: calcium sensing receptor agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and safety of Regpara in chronic dialysis patients with high blood levels of parathyroid
Regpara those taking 25 mg per day to get the default dose and the dose is adjusted according to the levels of calcium and parathyroid hormone. By adjusted dose of 25 mg every 3 weeks (weeks 3, 6, 9) for a period of 12 weeks, the drug is between 25-75 mg dose, with a maximum dose of not more than 100 mg per day .
Measured: Baseline to 36 week
Secondary outcomes (1)
Efficacy of the REGPARA in reducing the FGF23 level
The Regpara those taking 25 mg per day to get the default dose and the dose is adjusted according to the levels of calcium and parathyroid hormone. By adjusted dose of 25 mg every 3 weeks (weeks 3, 6, 9) for a period of 12 weeks, the drug is between 25-75 mg dose, with a maximum dose of not more than 100 mg per day .
Measured: baseline - 36 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionFeb 2015
- Study completionFeb 2015
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 Hyperparathyroidism, SecondaryStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kearkiat Praditpornsilpa, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056730
- Sponsor's protocol ID
- MDCU COA no.637/2013
- Other IDs
- IRB383/56
- Status last verified
- Feb 2015
- First submitted
- 28 Jan 2014
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Susantitaphong P, Vadcharavivad S, Susomboon T, Singhan W, Dumrongpisutikul N, Jakchairoongruang K, Eiam-Ong S, Praditpornsilpa K. The effectiveness of cinacalcet: a randomized, open label study in chronic hemodialysis patients with severe secondary hyperparathyroidism. Ren Fail. 2019 Nov;41(1):326-333. doi: 10.1080/0886022X.2018.1562356.
PubMed 31014177
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Efficacy and Safety of Calcium Sensing Receptor in Chronic Dialysis Patients
- ClinicalTrials.gov ID
- NCT02056730
- Acronym / sponsor ID
- MDCU COA no.637/2013
- Conditions
- Hyperparathyroidism, Secondary
- Keywords
- chronic hemodialysis patients, Hyperparathyroidism, Regpara, FGF 23
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 6 Feb 2014 (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 dialysis patient of chronic kidney disease and parathyroid hormone levels greater than or equal to 800 Pg per ml were divided into two groups by randomized 1:1, one group to receive medication and a control group that did not receive the medication. By group to receive in those taking 25 mg per day to get the default dose and the dose is adjusted according to the levels of calcium and parathyroid hormone. By adjusting the dose of 25 mg every 3 weeks for a period of 12 weeks, the drug is between 25-75 mg dose , with a maximum dose of not more than 100 mg per day (weeks 3, 6 , 9).
After a follow-up treatment in weeks 12, 24 and 36 with an blood,ultrasound test parathyroid glands , abdominal x-ray side . To evaluate the changes without the drug .Unless the track during treatment the patients with low blood calcium levels over 8.4 mg per dL . No dose adjustment . regpara while if blood calcium levels less than 7.5 mg per deciliter . Must be stop taking medication for patients in the control group will receive standard treatment . Which consisted of dose vitamin D sterol and parathyroid surgery . Unable to control the level of parathyroid hormone with vitamin D sterol.
While participating in the research are not allowed to adjust the amount of vitamin D sterol in the two groups . But the amount of dialysate calcium phosphate binders and can be adjusted as appropriate to healthcare is fine .
Detailed description
The renal impairment is caused FGF-23 resistance to the congestion of phosphate and stimulate the secretion of parathyroid hormone (PTH) from the parathyroid gland causes secondary hyperparathyroidism. They also found that high levels of FGF-23 is also a risk factor of vascular calcification.
The Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) is a disorder caused by renal impairment cause abnormalities occurring in the body. Can be summarized into three main parts as follows : 1) The disorders of minerals and hormones (laboratory abnormalities) such as hyperphosphatemia, secondary hyperparathyroidism. 2 ) The disorders of bone (bone abnormalities) , formerly known as renal osteodystrophy 3) The vascular calcification which results happened increase the risk of heart disease and stroke (cardiovascular disease) , broken bones (fractures) and death rate (mortality).
The secondary hyperparathyroidism. PTH secretion from parathyroid glands are more than normal and a major cause of the congestion of phosphate , reduced levels of 1,25-dihydroxyvitamin D [1,25 (OH) 2D] in the blood and a decrease in blood calcium levels decreased calcium levels in the blood is low. will result in a calcium (calcium sensing receptor or CaSR) on parathyroid glands make parathyroid cell signaling and increased PTH secretion .
That PTH increased continuously in the long run will cause the destruction of the bone called bone decay know "osteitis fibrosa". Some patients with a bone fracture. Important characteristics of osteitis fibrosa is an increase of bone destruction(osteoclastic bone resorption). In addition, the bone marrow may also be found associated with bone marrow fibrosis which causes anemia and did not respond to erythropoietin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Regpara | Experimental | Drug: calcium sensing receptor agonistcalcium sensing receptor agonist |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. The patient have age more equal 18 year on enrollment date. 2. The patient get the dialysis of 3 times per week 3. The parathyroid hormone level greater than or equal to 800 pg per mL during the screening 4.The calcium level in the blood is greater than or equal to 9 mg per dL.
Key exclusion criteria (7 listed)
- The patient had parathyroid gland surgery.
- The patient have a history of seizures within 12 weeks before randomized.
- The patient is scheduled for surgery the kidney
- The patient will expected parathyroid gland surgery within 6 months
- The liver function have abnormalities, including SGOT, SGPT, more than two fold
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 |
|---|---|---|
| calcium sensing receptor agonistAlso: RegparaFor the Regpara those taking 25 mg per day to get the default dose and the dose is adjusted according to the levels of calcium and parathyroid hormone. By adjusting the dose of 25 mg every 3 weeks for a period of 12 weeks, the drug is between 25-75 mg dose, with a maximum dose of not more than 100 mg per day (weeks 3, 6, 9). | Drug | Regpara |
Primary outcome
Efficacy and safety of Regpara in chronic dialysis patients with high blood levels of parathyroid
Time frame: Baseline to 36 week
Regpara those taking 25 mg per day to get the default dose and the dose is adjusted according to the levels of calcium and parathyroid hormone. By adjusted dose of 25 mg every 3 weeks (weeks 3, 6, 9) for a period of 12 weeks, the drug is between 25-75 mg dose, with a maximum dose of not more than 100 mg per day .
1 secondary outcome
Efficacy of the REGPARA in reducing the FGF23 level
Time frame: baseline - 36 week
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 Mar 2017.
- Derived from this study: PubMed 31014177Susantitaphong P, Vadcharavivad S, Susomboon T, Singhan W, Dumrongpisutikul N, Jakchairoongruang K, Eiam-Ong S, Praditpornsilpa K. The effectiveness of cinacalcet: a randomized, open label study in chronic hemodialysis patients with severe secondary hyperparathyroidism. Ren Fail. 2019 Nov;41(1):326-333. doi: 10.1080/0886022X.2018.1562356.
Related trials for Hyperparathyroidism, Secondary
RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder
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.
Kearkiat Praditpornsilpa, MD principal investigator
Chulalongkorn University
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 calcium sensing receptor agonist in people with Hyperparathyroidism, Secondary, run by Chulalongkorn University at 1 site in Thailand.
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 1 inclusion and 7 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 Mar 2017. 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 Thailand. 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?
Efficacy and safety of Regpara in chronic dialysis patients with high blood levels of parathyroid (time frame: Baseline to 36 week). 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 NCT02056730, 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 28 Mar 2017.