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

NCT06747247 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-02-06

No results posted yet for this study

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

Interventions

DRUG

Long-term Dosing Cohort

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.

DRUG

Single ascending doses of MT1013

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

DRUG

Multiple ascending doses of MT1013

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).

Sponsors & Collaborators

  • Shaanxi Micot Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-04-07
Primary Completion
2025-05-12
Completion
2025-05-12

Countries

  • China

Study Locations

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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 NCT06747247 on ClinicalTrials.gov