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

NCT02056730 | Completed Phase 4

• 2 other identifiers: MDCU COA no.637/2013IRB383/56
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 .

Conditions

Hyperparathyroidism, Secondary

Keywords

chronic hemodialysis patients; Hyperparathyroidism; Regpara; FGF 23

Outcome Measures

Primary Outcomes (1)

• 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 .

  Baseline to 36 week

Secondary Outcomes (1)

• Efficacy of the REGPARA in reducing the FGF23 level

  baseline - 36 week

Study Arms (1)

Regpara

EXPERIMENTAL

calcium sensing receptor agonist

Drug: calcium sensing receptor agonist

Interventions

calcium sensing receptor agonist DRUG

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).

Also known as: Regpara

Regpara

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn Memorial Hospital

Bangkok, Pathumwan, 10330, Thailand

Location

Related Publications (1)

• 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.

  PMID: 31014177 DERIVED

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Hyperparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Kearkiat Praditpornsilpa, MD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: February 6, 2014
• Study Start: November 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 28, 2017

Record last verified: 2015-02

Locations

TH (1)