Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
Conditions
Brief summary
This is a randomized, positive controlled, and placebo-controlled phase II clinical study to evaluate the efficacy and safety of MT1013 injection in the treatment of chronic kidney disease with secondary hyperparathyroidism (SHPT) undergoing maintenance hemodialysis (MHD) subjects.
Interventions
DRUGMT1013
MT1013 is a novel calcimimetic agent
the already-marketed therapeutic agents
DRUGPlacebo
The measure does not contain the active ingredients
Sponsors
Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Subject capable of understanding written information ,willing to participate in, and provide a written informed consent; * 2.Male or female subjects must be at least 18 years old when signing the informed consent; * 3.The subjects must undergo regular maintenance hemodialysis three times a week for at least three months； * 4.Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L); * 5.Diagnosed of Secondary Hyperparathyroidism (SHPT), with averaged iPTH ≥400 pg/ml14 days prior to screening; * 6.Receiving active vitamin D sterols must have had no more than a maximum dose change of 50% within the 1 month prior to screening, remain stable; * 7.Subject receiving calcium supplements, or phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening, remain stable;
Exclusion criteria
* 1.The subjects underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy or ablation or radiation during the study; * 2.Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening; * 3.The body mass index of the subjects was less than 18kg/m2 or greater than 35 kg/m2; * 4.Subjects with severe uncontrolled hypertension, defined as systolic blood pressure\>180 mmHg and/or diastolic blood pressure\>110 mmHg(Except for transient blood pressure abnormalities seen during dialysis), despite optimal drug treatment prior to enrollment; * 5.History of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening; * 6.Subjects with a history of malignant tumors within the past 5 years prior to screening; * 7.Subjects are allergic or intolerant to any component of the investigational drug or Etelcalcetide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with > 30% reduction from baseline in mean iPTH during the efficacy assessment phase | Weeks 22 to 27, inclusive |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants with > 50% reduction from baseline in mean iPTH during the efficacy assessment phase | Weeks 22 to 27, inclusive |
Countries
China
Outcome results
None listed