Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 3: testing MT1013 for Secondary Hyperparathyroidism, Chronic Kidney Disease
MT1013 is a first-in-class dual-target agonist. This study is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, double-dummy phase III clinical study being conducetd to measure the how well it works and safety of MT1013 compared with active control cinacalcet in secondary hyperparathyroidism patients on maintenance dialysis.
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are MT1013, or Cinacalcet. The registry lists allocation as randomized. MT1013 is a first-in-class dual-target agonist.
They plan to enroll about 424 people at Shanghai. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Multicenter, Randomized, Double-blind, Double-dummy, Phase III Study to Evaluate the Efficacy and Safety of MT1013 Versus Cinacalcet as Active Control in Secondary Hyperparathyroidism Patients on Maintenance Dialysis
Interventions: MT1013, Cinacalcet
Primary outcome (registry wording): Percentage of participants with > 50% reduction from baseline in mean intact parathyroid (iPTH)
Who it is for (from inclusion criteria)
Ages 18 Years to any
Male or female, at least 18 years old, 18 kg/m\^2 ≤body-mass index (BMI)≤35 kg/m\^2;
Receiving regular maintenance dialysis 3 times a week for at least 12 weeks prior to screening；
Within 14 days prior to randomization, subjects must have serum calcium levels (measured pre-dialysis, or corrected serum calcium if albumin \<40 g/L) ≥ 8.4 mg/dL (2.1 mmol/L) on two non-consecutive pre-dialysis measurements
Who the registry excludes
Underwent parathyroidectomy within 6 months prior to screening, or anticipated parathyroidectomy, ablation or radiation during the study;
Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
New York Heart Association (NYHA) Class III or IV heart failure within 3 months prior to screening; Symptomatic arrhythmia within 6 months prior to screening; History of torsades de pointes (TdP)
History of seizure within 1 year prior to screening, or currently receiving treatment for seizure disorders;
Received oral cinacalcet or ivocalcet within 14 days prior to screening, or received Etelcalcetide injection treatment within 4 months prior to screening;
Any other condition that, in the Investigator's judgment, would make the subject unsuitable for participation in this study
Kidney diseases related to the immune system include, nephrotic syndrome, glomerulonephritis, membranous nephropathy, lupus nephritis, and nephritis associated with connective tissue disorders. This study will allow researchers to admit and follow patients suffering from autoimmune diseases of the kidney.
The purpose of the study is to create a Nephrology Tissue Biobank enabling the study of kidney disease from the perspectives of epidemiology, genetics and molecular biology.
Pro-Kids is a multi-center, neither you nor the study doctors know who gets the real treatment, randomly assigned and compared with a dummy treatment intervention study in children with chronic kidney disease. The investigators address the effect of a dietary food supplementation of propionic acid on the immune system and the function of the intestinal barrier in CKD patients treated with hemodialysis.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07122401?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07122401?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.