An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is an intra-individual titration study of KRN1493 to evaluate the safety and efficacy of KRN1493 for the treatment of hypercalcemia in patients with parathyroid carcinoma or intractable primary hyperparathyroidism (PHPT).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism

NCT03878953

Chronic Hypoparathyroidism

WITHDRAWN PHASE3

Antithyroid Drug Treatment of Thyrotoxicosis in Young People

NCT01436994

Paediatric Thyrotoxicosis

COMPLETED PHASE3

A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism

NCT02910466

Chronic Hypoparathyroidism Hypoparathyroidism

COMPLETED PHASE4

Study of Resistance to Thyroid Hormone After Long-term Exposure in People With Thyroid Cancer

NCT04868045

Thyroid Cancer

WITHDRAWN PHASE1

Primary Hyperparathyroidism: Short-term Calcimimetics Treatment - Relevance for Parathyroid Surgery Decisions?

NCT02227264

Primary Hyperparathyroidism

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parathyroid Carcinoma Hypercalcemia Primary Hyperparathyroidism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

KRN1493

Group Type EXPERIMENTAL

Cinacalcet HCl

Intervention Type DRUG

Oral administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cinacalcet HCl

Oral administration

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who meet any one of the following. Patients with a diagnosis of parathyroid carcinoma and corrected serum calcium \> 11.3 mg/dL at the latest screening test. Patients with intractable PHPT (defined as follows: impossible to localize parathyroid tumor before initial surgery or in relapse after surgery, or impossible to perform parathyroidectomy (PTx) for complications, and corrected serum calcium is \> 12.5 mg/dL at the screening test).
* Patients who provided their voluntary written informed consent to participate in the study.

Exclusion Criteria

* Patients diagnosed with malignant tumor except for parathyroid carcinoma, nonmelanoma skin cancer, and carcinoma in situ of the cervix within 5 years before enrollment.
* Patients receiving anticancer chemotherapy except for the treatment of parathyroid carcinoma.
* Patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma.
* Patients who had hypersensitivities to cinacalcet HCl preparations or vehicles.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No