Clinical trial · Interventional
Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
A Dose Escalation, Single and Multiple Dose, Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
NCT01935856CI-TRIAL-00026230completedPhase 1 / Phase 2ClinicalTrials.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 study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single and multiple administration of KHK7580 for secondary hyperparathyroidism in patients receiving hemodialysis
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyperparathyroidism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KHK7580 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- KHK7580
- interventionNames
- Drug: KHK7580
Primary outcomes (1)
- measure
- The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination
- timeFrame
- For 19 weeks
- description
- The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination
Secondary outcomes (2)
- measure
- Profiles of pharmacokinetics
- timeFrame
- Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hours post each single dosing, and pre-dose in Day 1, 3, 5, 8, 12 and 15 in multiple dose period
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Stable chronic renal disease patients receiving hemodialysis 3 times weekly for at least 12 weeks prior to the screening * intact PTH value ≥ 240 pg/mL at the screening * Corrected serum calcium ≥ 8.4 mg/dL at the screening Exclusion Criteria: * Patients with primary hyperparathyroidism * Patients who received cinacalcet within 2 weeks prior to the screening * Patients with change in dose or dosing regimen of active vitamin D/ its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening * Patients who received parathyroidectomy and/or parathyroid intervention * Patients with uncontrolled hypertension and/or diabetes * Patients with severe heart disorder * Patients with severe hepatic disease * Patients who take investigational drug in other clinical trial within 12 weeks prior to the screening * Patients who have been judged ineligible to participate in the study by the investigator
References
Publications (0)
Data not yet available
No reference posted for this study.