Clinical trial · Interventional
An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism
NCT01460030CI-TRIAL-00026260completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypercalcemia | — | UNRESOLVED | — |
| Parathyroid Carcinoma | Parathyroid Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Primary Hyperparathyroidism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cinacalcet HCl | Drug | Cinacalcet | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- KRN1493
- interventionNames
- Drug: Cinacalcet HCl
Primary outcomes (1)
- measure
- Corrected serum calcium
Secondary outcomes (1)
- measure
- Serum intact parathyroid hormone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.