A Clinical Study Evaluating the Safety, Tolerability, and Efficacy of MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism

NCT06747247 | Completed Phase 2

• 1 other identifier: MT1013-II-C01
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, Phase II, randomized, double-blind, single ascending dose (SAD) and multiple ascending dose (MAD), as well as single-arm clinical study evaluating the long-term efficacy and safety of MT1013 in hemodialysis subjects with secondary hyperparathyroidism. The SAD study consists of five cohorts at doses of 5, 10, 20, 40, and 60 mg. The MAD study consists of three cohorts at doses of 5, 10, and 20 mg. In both the SAD and MAD studies, each cohort includes 8 subjects (6 subjects receive the active investigational drug, and 2 subjects receive matching placebo), and the cohorts are conducted sequentially. In the long-term dosing cohort, all subjects will undergo regular hemodialysis three times per week, receiving the drug once after each hemodialysis session for a total duration of 52 weeks

Conditions

Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis

Outcome Measures

Primary Outcomes (2)

• SAD/MAD :Percentage of treatment-emergent adverse events (TEAEs)

  To investigate the safety and tolerability of MT1013 by assessing the incidence and severity of TEAEs in Single Ascending Dose (SAD Cohort) and Multiple Ascending Doses (MAD Cohort)

  SAD：on Day 8±1. MAD：on Day 16+2 or 30+2 and Day 21±2 or 35±2

• Long-term Dosing Cohort: Proportion of subjects with > 30% reduction in serum iPTH compared to baseline level.

  Proportion of subjects achieving a \>30% reduction in serum iPTH from baseline at Week 14.

  14 weeks

Secondary Outcomes (18)

• Change in the mean serum intact parathyroid hormone (iPTH) from baseline

  SAD：on Day 8±1. MAD：on Day 16+2 or 30+2 and Day 21±2 or 35±2. Long-term Dosing Cohort: 52 weeks

• Proportion of subjects achieving a >30% reduction in serum iPTH from baseline

  SAD：on Day 8±1. MAD：on Day 16+2 or 30+2 and Day 21±2 or 35±2. Long-term Dosing Cohort: 52 weeks

• Change from baseline in corrected Ca

  SAD：on Day 8±1. MAD：on Day 16+2 or 30+2 and Day 21±2 or 35±2. Long-term Dosing Cohort: 52 weeks

• Change from baseline in ionized calcium

  SAD：on Day 8±1. MAD：on Day 16+2 or 30+2 and Day 21±2 or 35±2

• Change in DXA-measured bone mineral density (BMD) at the femoral neck and lumbar spine from baseline

  Long-term Dosing Cohort: 52 weeks

Study Arms (5)

MT1013 for SAD

EXPERIMENTAL

Single ascending doses of MT1013

Drug: Single ascending doses of MT1013

Placebo for SAD

PLACEBO COMPARATOR

Placebo comparator for SAD

Drug: Single ascending doses of MT1013

MT1013 for MAD

EXPERIMENTAL

Multiple ascending doses of MT1013

Drug: Multiple ascending doses of MT1013

Placebo for MAD

PLACEBO COMPARATOR

Placebo comparator for MAD

Drug: Multiple ascending doses of MT1013

Long-term Dosing Cohort

EXPERIMENTAL

Dose titration period covers the first 10 weeks , followed by maintenance dosing period, for a total treatment duration of 52 weeks

Drug: Long-term Dosing Cohort

Interventions

Long-term Dosing Cohort DRUG

All subjects will undergo regular hemodialysis three times per week. Administration of MT1013occurs once after each hemodialysis session and will continue for 52 weeks. The first 10 weeks constitute the dose-titration period, during which the drug dose is titrated every 3 weeks based on iPTH and serum corrected calcium levels. During the maintenance dosing period, doses is adjusted based on iPTH and serum corrected calcium levels.

Long-term Dosing Cohort

Single ascending doses of MT1013 DRUG

All subjects will receive a single dose (MT1013 or placebo) only after a single hemodialysis session

MT1013 for SAD; Placebo for SAD

Multiple ascending doses of MT1013 DRUG

All subjects will undergo hemodialysis three times per week. Dosing (MT1013 or placebo) will occur once after each hemodialysis session, continuing for either 2 or 4 weeks (treatment period).

MT1013 for MAD; Placebo for MAD

Eligibility Criteria

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

You may qualify if:

• Male or non- pregnant, non-lactating female aged 18 to 80;
• The patient has been on stable, adequate hemodialysis treatment for \>3 months prior to screening;
• Intact parathyroid hormone (iPTH) level of at least 300 pg/mL;
• Serum calcium (corrected serum calcium if albumin \<40 g/L) ≥2.25 mmol/L (9.0mg/dL);
• Hemoglobin ≥ 8.0 g/dL;
• Subject is clinically stable, as judged by medical history, physical examination, and routine laboratory tests, apart from chronic renal failure;
• Able to understand and willing to sign the written informed consent form;
• Women of childbearing potential must have a negative pregnancy test result prior to enrollment, or be postmenopausal for at least 1 year, or be permanently sterile(i.e., documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) for ≥6 weeks. Fertile men with partners of childbearing potential and women of childbearing potential must use effective contraception (i.e., any combination of two of the following: male or female condom with spermicidal gel,diaphragm, sponge, or cervical cap with spermicidal gel) from signing the informed consent until 90 days after MT1013 infusion.
• Postmenopausal is defined as:
• Age ≥55 years \& amenorrhea for ≥12 months;
• Or Age \<55 years but no spontaneous menses for at least 2 years;
• Or Age \<55 years with spontaneous menses within the past 1 year, but currently amenorrheic, and with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels \>40 IU/L) or postmenopausal estradiol levels (\<5.3 pmol/L or 5 ng/dL) or meeting the laboratory's definition of "postmenopausal range";Having undergone bilateral oophorectomy.

You may not qualify if:

• History of severe ventricular arrhythmia or symptomatic ventricular arrhythmia at screening, or QTc \>470 ms for males or \>480 ms for females at screening;
• \. Subjects with heart failure symptoms，class III or IV by New York Heart Association (NYHA) ， at screening;
• \. History of myocardial infarction, coronary angioplasty, or coronary artery bypass graft within the past 6 months;
• \. History of seizures or having received treatment for seizures;
• \. Prior parathyroidectomy;
• \. Serum transaminases (alanine aminotransferase, aspartate aminotransferase) \>3 times the upper limit of normal at screening; or serum albumin \<30 g/L;
• History of organ transplant (excluding being on the kidney transplant waiting list), hematopoietic stem cell transplant, or bone marrow transplant; or patients planning to undergo organ transplantation;
• Severe uncontrolled hypertension, defined as systolic blood pressure \>180 mmHg and diastolic blood pressure \>100 mmHg despite optimal medical therapy before enrollment;
• Known malignancy or other comorbidities with a life expectancy of \<3 months (except for patients disease-free for ≥5 years, or disease-free for ≥5 years after the last dose of chemotherapy );
• Known alcohol or illicit drug abuse within 12 months prior to screening, unwillingness or inability to abstain from alcohol for 24 hours prior to each study visit, or unwillingness or inability to limit alcohol consumption to a maximum of 2 drinks per day during the study (one drink is equivalent to 360 mL of regular beer, 150 mL of wine, or 45 mL of 40% alcohol spirits);
• Positive for human immunodeficiency virus (HIV) or known diagnosis of acquired immunodeficiency syndrome (AIDS) at screening;
• Subjects positive for hepatitis B surface antigen (HBsAg) at screening (indicative of chronic hepatitis B) AND with serum transaminases (alanine aminotransferase, aspartate aminotransferase) \>2 times the upper limit of normal;
• Positive for hepatitis C virus ribonucleic acid (RNA) by polymerase chain reaction (PCR) at screening (indicative of active hepatitis C - usually screened via hepatitis C antibody \[HCV-Ab\], with PCR for HCV RNA if HCV-Ab positive);
• Patients with known hypersensitivity to the investigational product and/or its components;
• Patients who have participated in another clinical trial and received an investigational drug within 8 weeks prior to the first dose or within 5 half-lives of the investigational drug (whichever is longer);

Sponsors & Collaborators

• Shaanxi Micot Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

First Affiliated Hospital College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study consists of the following three cohorts: SAD Cohort: All subjects will receive a single dose only after a single hemodialysis session and will be followed up on Day 8±1. MAD Cohort: All subjects will undergo regular hemodialysis three times per week. Dosing will occur once after each hemodialysis session, continuing for either 2 or 4 weeks (treatment period). Subjects will undergo safety follow-up on Day 16+2 or 30+2 and Day 21±2 or 35±2. Long-term Dosing Cohort: All subjects will undergo hemodialysis three times per week. Dosing will occur once after each hemodialysis session and will continue for 52 weeks. The first 10 weeks constitute the dose titration period, during which the drug dose is titrated every 3 weeks based on iPTH and serum corrected calcium levels. During other treatment periods, the drug dose may be adjusted based on iPTH and serum corrected calcium levels.

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: April 7, 2023
• Primary Completion: May 12, 2025
• Study Completion: May 12, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

CN (1)