MedPath

Cinacalcet

Generic Name
Cinacalcet
Brand Names
Mimpara, Sensipar, Cinacalcet Mylan, Cinacalcet Accordpharma
Drug Type
Small Molecule
Chemical Formula
C22H22F3N
CAS Number
226256-56-0
Unique Ingredient Identifier
UAZ6V7728S
Background

Cinacalcet is a calcimimetic sold by Amgen under the trade name Sensipar® in North America and Australia and as Mimpara® in Europe. It is used to treat hyperparathyroidism due to parathyroid tumours or renal failure.

Indication

For the treatment of secondary hyperparathyroidism in patients with Chronic Kidney Disease who are on hemodialysis or peritoneal dialysis. Also for the treatment of hypercalcemia in patients with parathyroid carcinoma.

Associated Conditions
Hypercalcemia, Secondary Hyperparathyroidism (SHPT)

Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Patients With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy

Phase 3
Completed
Conditions
Hypercalcemia
Hyperparathyroidism, Primary
Interventions
Drug: Placebo
First Posted Date
2009-09-11
Last Posted Date
2018-10-17
Lead Sponsor
Amgen
Target Recruit Count
67
Registration Number
NCT00975221
Locations
🇷🇺

Research Site, Yaroslavl, Russian Federation

Pharmacokinetic, Pharmacodynamic and Safety Evaluation After Single Oral Administration of KRN1493

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-08-04
Last Posted Date
2009-08-04
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
39
Registration Number
NCT00952094
Locations
🇰🇷

Seoul National University Hospital Clinical Trial Center, Seoul, Korea, Republic of

A Study to Assess the Efficacy and Safety of Twice-Daily Dose Regimens of an Oral Calcimimetic Agent AMG 073 (Cinacalcet) in Primary Hyperparathyroidism (PHPT)

Phase 2
Completed
Conditions
Hyperparathyroidism, Primary
Interventions
Drug: placebo
First Posted Date
2009-07-10
Last Posted Date
2013-05-08
Lead Sponsor
Amgen
Target Recruit Count
78
Registration Number
NCT00936650

A Multicenter, Open-label Extension Study to Assess the Long-term Safety and Efficacy of an Oral Calcimimetic Agent AMG 073 (Cinacalcet) in Primary Hyperparathyroidism

Phase 2
Completed
Conditions
Hyperparathyroidism, Primary
Interventions
First Posted Date
2009-07-10
Last Posted Date
2013-05-08
Lead Sponsor
Amgen
Target Recruit Count
45
Registration Number
NCT00936988

PRIMARA: A Prospective Descriptive Observational Study to Review Mimpara (Cinacalcet) Use in Patients With Primary Hyperparathyroidism in Clinical Practice

Completed
Conditions
Hyperparathyroidism, Primary
Interventions
First Posted Date
2009-06-26
Last Posted Date
2018-08-01
Lead Sponsor
Amgen
Target Recruit Count
305
Registration Number
NCT00928408

Calcimimetics in Hypophosphatemic Rickets

Not Applicable
Withdrawn
Conditions
Familial Hypophosphatemic Rickets
Interventions
First Posted Date
2009-02-16
Last Posted Date
2020-12-17
Lead Sponsor
Children's Mercy Hospital Kansas City
Registration Number
NCT00844740
Locations
🇺🇸

Children's Mercy Hospital, Kansas City, Missouri, United States

20070360 Incident Dialysis

Phase 4
Completed
Conditions
Secondary Hyperparathyroidism
Chronic Kidney Disease
Interventions
First Posted Date
2008-12-05
Last Posted Date
2018-10-17
Lead Sponsor
Amgen
Target Recruit Count
313
Registration Number
NCT00803712

Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects

Phase 3
Completed
Conditions
Hyperparathyroidism
Interventions
Drug: Placebo
First Posted Date
2007-09-10
Last Posted Date
2009-01-26
Lead Sponsor
Amgen
Target Recruit Count
320
Registration Number
NCT00527267

12-month Study of AMG 073 in Renal Osteodystrophy

Phase 2
Completed
Conditions
Renal Osteodystrophy
Interventions
Drug: Placebo
First Posted Date
2007-09-10
Last Posted Date
2013-05-08
Lead Sponsor
Amgen
Target Recruit Count
45
Registration Number
NCT00527085

Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

Phase 4
Terminated
Conditions
Secondary Hyperparathyroidism
First Posted Date
2007-03-12
Last Posted Date
2014-10-29
Lead Sponsor
Papageorgiou General Hospital
Target Recruit Count
15
Registration Number
NCT00446329
Locations
🇬🇷

Papageorgiou General Hospital, Thessaloniki, Greece

© Copyright 2025. All Rights Reserved by MedPath