MedTrace Logo

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

NCT02056730 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-03-28

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Kearkiat Praditpornsilpa, MD · Chulalongkorn University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Thailand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02056730 on ClinicalTrials.gov