Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Study of Efficacy and Safety of REGPARA Drug in Dialysis Patients Have High Blood Levels of Parathyroid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02056730
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Chulalongkorn University

Brief 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. 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 .


Condition or disease Intervention/treatment Phase
Hyperparathyroidism, Secondary Drug: calcium sensing receptor agonist Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Study of Efficacy and Safety of Calcium Sensing Receptor in Chronic Dialysis Patients
Study Start Date : November 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Dialysis

Arm Intervention/treatment
Experimental: Regpara
calcium sensing receptor agonist
Drug: calcium sensing receptor agonist
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).
Other Name: Regpara




Primary Outcome Measures :
  1. 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 .


Secondary Outcome Measures :
  1. Efficacy of the REGPARA in reducing the FGF23 level [ Time Frame: baseline - 36 week ]
    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 .



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  1. The patient had parathyroid gland surgery.
  2. The patient have a history of seizures within 12 weeks before randomized.
  3. The patient is scheduled for surgery the kidney
  4. The patient will expected parathyroid gland surgery within 6 months
  5. The liver function have abnormalities, including SGOT, SGPT, more than two fold
  6. The patient had history received a drug of bisphosphonates group or expected to be received during the study.
  7. The patient had a history of cancer. Pregnant women. Lactating women. And with sepsis -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056730


Locations
Layout table for location information
Thailand
Chulalongkorn Memorial Hospital
Bangkok, Pathumwan, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
Layout table for investigator information
Principal Investigator: Kearkiat Praditpornsilpa, MD Chulalongkorn University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02056730     History of Changes
Other Study ID Numbers: MDCU COA no.637/2013
IRB383/56 ( Other Identifier: Chulalongkorn University )
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: February 2015
Keywords provided by Chulalongkorn University:
chronic hemodialysis patients
Hyperparathyroidism
Regpara
FGF 23
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperparathyroidism
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases
Calcium, Dietary
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents