Last reviewed · How we verify
NCT03123406: ACTIVE
Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT
Phase 4 trial testing Cinacalcet HCl in Hyperparathyroidism; Secondary, Renal in 750 participants. Completed in 6 September 2019.
20 April 2019
Quick facts
| Lead sponsor | Kyowa Kirin China Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 750 |
| Start date | 19 April 2017 |
| Primary completion | 20 April 2019 |
| Estimated completion | 6 September 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
- Cinacalcet HCl — full drug profile →
Conditions studied
- Hyperparathyroidism; Secondary, Renal — all drugs for Hyperparathyroidism; Secondary, Renal →
Sponsor
Kyowa Kirin China Pharmaceutical Co., Ltd.
Who can join
Adults 18 to 75, any sex, with Hyperparathyroidism; Secondary, Renal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
1. To evaluate achievement ratio of iPTH,Calcium and phosphorus after taking Cinacalcet HCL in hemodialysis subjects with mild, moderate and severe SHPT; 2. To explore the impact of Cinacalcet HCL using on the combined use of drugs; 3. To explore the difference of patients who continued or discontinued Cinacalcet HCL in real-world period from 33rd to 52nd week.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03123406
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cinacalcet HCl
Trials testing the same drug.
- NCT02138838 — Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Dis · Phase 3 · terminated
Other Kyowa Kirin China Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT06285370 — A Study to Evaluate the Efficacy and Safety of KW-0761 in Chinese Subjects With Mycosis Fungoides or Sézary Syndrome Pre · Phase 4 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03123406 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kyowa Kirin China Pharmaceutical Co., Ltd.
- Last refreshed: 29 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03123406.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing