MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease

Shaanxi Micot Technology

Status and phase: Enrolling; Phase 2

Conditions: Secondary Hyperparathyroidism (SHPT) in Subjects with Chronic Kidney Disease (CKD) on Hemodialysis

Treatments: Drug: Etelcalcetide Hydrochloride; Drug: Placebo; Drug: MT1013

Study type: Interventional

Funder types: Industry

Identifiers

NCT06690242

MT1013-II-C03

Details and patient eligibility

About

This is a randomized, single-blind, 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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 during the study;
• 2.Diagnosed with gastrointestinal bleeding or peptic ulcer within 6 months prior to screening;
• 3.The body mass index of the subjects was less than 18kg/m2 or greater than 32.5 kg/m2;
• 4.Subjects with severe uncontrolled hypertension, defined as systolic blood pressure>180 mmHg and/or diastolic blood pressure>110 mmHg, 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 4 patient groups, including a placebo group

MT1013 dose regimen 1

Experimental group

Description:

MT1013 injection dose regimen 1 administered intravenously (IV) three times per week for 26 weeks.

Treatment:

Drug: MT1013

Drug: MT1013

MT1013 dose regimen 2

Experimental group

Description:

MT1013 injection dose regimen 2 administered intravenously (IV) three times per week for 26 weeks.

Treatment:

Drug: MT1013

Drug: MT1013

Etelcalcetide

Active Comparator group

Description:

Etelcalcetide injection administered intravenously (IV) three times per week for 26 weeks.

Treatment:

Drug: Etelcalcetide Hydrochloride

Placebo

Placebo Comparator group

Description:

Placebo administered intravenously (IV) three times per week for 26 weeks;

Treatment:

Drug: Placebo