Clinical Trials

Cinacalcet (AMG-073) HCl has been evaluated in numerous clinical trials across Phases 1 through 4, primarily investigating its utility in secondary hyperparathyroidism associated with chronic kidney disease or end-stage renal disease, primary hyperparathyroidism, osteomalacia, and familial hypophosphatemic rickets. Sponsored by diverse academic medical centers, government institutes, and pharmaceutical organizations, these studies feature dose-titration and combination therapy designs. The overall body of research encompasses completed, active, recruiting, terminated, and withdrawn trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06288451 ACTIVE_NOT_RECRUITING
Kidney Failure, Chronic; Chronic Kidney Disease-Mineral and Bone Disorder
University of Washington
 2024-03-11 PHASE2
NCT07122401 RECRUITING
Secondary Hyperparathyroidism, Chronic Kidney Disease
Shaanxi Micot Pharmaceutical Technology Co., Ltd.
 2025-09-30 PHASE3
NCT06434961 COMPLETED
Secondary Hyperparathyroidism
Shanghai Hengrui Pharmaceutical Co., Ltd.
 2024-06-14 PHASE3
NCT03994172 COMPLETED
Male Osteoporosis
VA Office of Research and Development
 2019-07-01 PHASE4
NCT05926570 COMPLETED
Drug Effect
Tanta University
 2023-08-05 PHASE4
NCT05663411 UNKNOWN
Secondary Hyperparathyroidism
Shanghai Hengrui Pharmaceutical Co., Ltd.
 2023-02-24 PHASE2
NCT05926570 Completed
Drug Effect
Tanta University
 2023-08-05 Phase 4
NCT02227264 COMPLETED
Primary Hyperparathyroidism
Karolinska University Hospital
 2014-06
NCT02525796 COMPLETED
Primary Hyperparathyroidism
Brigham and Women's Hospital
 2016-01 PHASE2; PHASE3
NCT03822507 COMPLETED
Secondary Hyperparathyroidism
Kyowa Kirin Co., Ltd.
 2019-04-09 PHASE3
NCT02440581 COMPLETED
Kidney Failure, Chronic
Hartmut Malluche, MD
 2015-07-01
NCT03299244 COMPLETED
Secondary Hyperparathyroidism; Chronic Kidney Disease
Amgen
 2018-05-15 PHASE3
NCT03123406 COMPLETED
Hyperparathyroidism; Secondary, Renal
Kyowa Kirin China Pharmaceutical Co., Ltd.
 2017-04-19 PHASE4
NCT03027557 COMPLETED
Primary Hyperparathyroidism; Parathyroid Adenoma; Parathyroid Hyperplasia
Peter Vestergaard
 2017-03-01 PHASE3
NCT04637360 COMPLETED
Hyperparathyroidism; Secondary, Renal
Min-Sheng General Hospital
 2018-01-01
NCT01447368 COMPLETED
Kidney Failure; Secondary Hyperparathyroidism; Vascular Diseases
The University of Hong Kong
 2010-05-10 PHASE4
NCT03123406 Completed
Hyperparathyroidism; Secondary Renal
Kyowa Kirin China Pharmaceutical Co. Ltd.|Kyowa Kirin Co. Ltd.
 2017-04-19 Phase 4
NCT02341417 COMPLETED
Secondary Hyperparathyroidism, Chronic Kidney Disease
Amgen
 2015-06-10 PHASE3
NCT02338934 UNKNOWN
Secondary Hyperparathyroidism
Penang Hospital, Malaysia
 2015-01 PHASE4
NCT01748812 TERMINATED
Osteomalacia
National Institute of Dental and Craniofacial Research (NIDCR)
 2012-11-16 PHASE1
NCT02549391 COMPLETED
Secondary Hyperparathyroidism
Kyowa Kirin Co., Ltd.
 2015-09 PHASE2; PHASE3
NCT02138838 TERMINATED
Chronic Kidney Disease, Secondary Hyperparathyroidism
Amgen
 2014-11-07 PHASE3
NCT01439867 TERMINATED
Chronic Kidney Disease; Hyperparathyroidism, Secondary
Amgen
 2012-06-22 PHASE2
NCT01011114 TERMINATED
Hypophosphatemia; Renal Transplant
Montefiore Medical Center
 2009-11
NCT01290029 COMPLETED
Chronic Kidney Disease; Hyperparathyroidism, Secondary; Secondary Hyperparathyroidism
Amgen
 2011-01-25 PHASE1
NCT02341417 Completed
Secondary Hyperparathyroidism Chronic Kidney Disease
Amgen
 2015-06-10 Phase 3
NCT01896232 COMPLETED
Secondary Hyperparathyroidism; Chronic Kidney Disease
Amgen
 2013-08-13 PHASE3
NCT02133404 COMPLETED
Secondary Hyperparathyroidism
Astellas Pharma Inc
 2014-03-14 PHASE2
NCT01178450 COMPLETED
Secondary Hyperparathyroidism
Josep M Cruzado
 2010-01 PHASE4
NCT01054079 COMPLETED
Adenocarcinoma of the Prostate; Recurrent Prostate Cancer
Wake Forest University Health Sciences
 2011-09 PHASE2
NCT01277510 TERMINATED
Chronic Kidney Disease; Hyperparathyroidism; Hyperparathyroidism, Secondary; Kidney Disease; Secondary Hyperparathyroidism
Amgen
 2011-06-28 PHASE3
NCT01250405 COMPLETED
Chronic Kidney Disease
Laval University
 2012-05 PHASE4
NCT01932970 COMPLETED
Hyperparathyroidism, Secondary
Amgen
 2013-08-12 PHASE3
NCT01479088 UNKNOWN
Secondary Hyperparathyroidism
ENRICO VERRINA
 2010-03 PHASE2; PHASE3
NCT01011699 TERMINATED
Chronic Renal Failure; Hemodialysis
Centre Hospitalier Universitaire, Amiens
 2010-01 PHASE3
NCT01103206 COMPLETED
Parathyroid Hormone Suppression Test With Cinacalcet
University Hospital, Rouen
 2010-04 PHASE4
NCT01143987 COMPLETED
Hyperparathyroidism; Arterial Stiffness
Chinese University of Hong Kong
 2010-06 PHASE4
NCT01460030 COMPLETED
Parathyroid Carcinoma; Hypercalcemia; Primary Hyperparathyroidism
Kyowa Kirin Co., Ltd.
 2011-11 PHASE3
NCT01748812 Terminated
Osteomalacia
National Institute of Dental and Craniofacial Research (NIDCR)|National Institutes of Health Clinical Center (CC)
 2012-11-16 Phase 1
NCT00975000 COMPLETED
Chronic Allograft Nephropathy; Chronic Kidney Disease; Chronic Renal Failure; Disordered Mineral Metabolism; End Stage Renal Disease; Hyperparathyroidism; Hypophosphatemia; Kidney Disease; Kidney Transplantation; Post Renal Transplantation
Amgen
 2009-12-03 PHASE3
NCT01599962 COMPLETED
Memory Functions
Prof. Dominique de Quervain, MD
 2012-03 PHASE2
NCT01181531 COMPLETED
Hyperparathyroidism, Secondary
Amgen
 2010-10-01 PHASE4
NCT00975221 COMPLETED
Hyperparathyroidism, Primary; Hypercalcemia
Amgen
 2010-03-10 PHASE3
NCT01519037 COMPLETED
Relationship Between Calcimimetic and the RAAS
Centre Hospitalier Universitaire Vaudois
 2012-01
NCT01439867 Terminated
Chronic Kidney Disease|Hyperparathyroidism Secondary
Amgen
 2012-06-22 Phase 2
NCT00345839 COMPLETED
Secondary Hyperparathyroidism; Chronic Kidney Disease
Amgen
 2006-08-22 PHASE3
NCT00844740 WITHDRAWN
Familial Hypophosphatemic Rickets
Children's Mercy Hospital Kansas City
 2009-03-01
NCT01101113 COMPLETED
Secondary Hyperparathyroidism
Seoul National University Hospital
 2010-09 PHASE4
NCT01573520 COMPLETED
Hyperparathyroidism; Chronic Kidney Disease
Michel Burnier
 2010-01 PHASE4
NCT02417389 COMPLETED
Hyperparathyroidism, Primary; Osteoporosis
Istituto Auxologico Italiano
 2008-05 PHASE4
NCT01100723 COMPLETED
Secondary Hyperparathyroidism; Chronic Kidney Disease
University of Colorado, Denver
 2010-03 PHASE4
NCT00977080 COMPLETED
Chronic Kidney Disease; Secondary Hyperparathyroidism; Hemodialysis
Abbott
 2009-11 PHASE4
NCT00261950 COMPLETED
Secondary Hyperparathyroidism
Amgen
 2006-05 PHASE2
NCT00803712 COMPLETED
Chronic Kidney Disease; Secondary Hyperparathyroidism
Amgen
 2009-02-01 PHASE4
NCT00656032 COMPLETED
End Stage Renal Disease
Vanderbilt University
 2008-04 PHASE2
NCT00415584 TERMINATED
Secondary Hyperparathyroidism; Hypercalcemia
Montefiore Medical Center
 2007-02-09 PHASE1; PHASE2
NCT00431496 COMPLETED
Anemia; Secondary Hyperparathyroidism
Amgen
 2006-09 PHASE4
NCT00379899 COMPLETED
Chronic Kidney Disease; End Stage Renal Disease; Coronary Artery Calcification; Vascular Calcification; Calcification; Cardiovascular Disease; Chronic Renal Failure; Hyperparathyroidism; Kidney Disease; Nephrology; Secondary Hyperparathyroidism
Amgen
 2006-09 PHASE4
NCT00195936 COMPLETED
Hypophosphatemic Rickets, X-Linked Dominant
Children's Mercy Hospital Kansas City
 2005-06 PHASE1
NCT00117052 COMPLETED
Secondary Hyperparathyroidism; End Stage Renal Disease
Amgen
 2004-09 PHASE3
NCT00936988 COMPLETED
Hyperparathyroidism, Primary
Amgen
 2000-11 PHASE2
NCT00110890 COMPLETED
End Stage Renal Disease
Amgen
 2004-05 PHASE4
NCT00527085 COMPLETED
Renal Osteodystrophy
Amgen
 2001-10 PHASE2
NCT00042653 COMPLETED
Secondary Hyperparathyroidism; End Stage Renal Disease
Amgen
 2002-05 PHASE3
NCT00527267 COMPLETED
Hyperparathyroidism
Amgen
 2002-02 PHASE3
NCT00042432 COMPLETED
Secondary Hyperparathyroidism; Chronic Renal Insufficiency
Amgen
 2002-06 PHASE2
NCT00037635 COMPLETED
Secondary Hyperparathyroidism; End Stage Renal Disease
Amgen
 2001-12 PHASE3
NCT00936650 COMPLETED
Hyperparathyroidism, Primary
Amgen
 1999-11 PHASE2
NCT03776058 COMPLETED
Primary Hyperparathyroidism
Amgen
 2000-06-15 PHASE2
NCT03774771 COMPLETED
Primary Hyperparathyroidism
Amgen
 1998-09-29 PHASE2
NCT00113958 COMPLETED
End Stage Renal Disease
Amgen
 PHASE2
NCT00336739 COMPLETED
Healthy
Tufts University
 2006-04
NCT00325104 COMPLETED
Hypercalcemia; Familial Primary Hyperparathyroidism
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2006-05-09 PHASE3
NCT00094484 COMPLETED
Kidney Disease; Chronic Kidney Disease
Amgen
 2004-10 PHASE3
NCT00113945 COMPLETED
End Stage Renal Disease
Amgen
 2003-07 PHASE2
NCT00446329 TERMINATED
Secondary Hyperparathyroidism
Papageorgiou General Hospital
 2006-07 PHASE4
NCT00110929 COMPLETED
End Stage Renal Disease
Amgen
 2002-11 PHASE2
NCT00037518 COMPLETED
Hyperparathyroidism; Parathyroid Neoplasms
Amgen
 2001-04 PHASE4

(data from https://clinicaltrials.gov, updated on 2025-06-02)

Check the Cinacalcet (AMG-073) HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cinacalcet hydrochloride acts as a calcimimetic that directly binds to and allosterically increases the sensitivity of the transmembrane calcium-sensing receptor to extracellular calcium ions. This conformational change suppresses intracellular signaling pathways driving parathyroid hormone synthesis and secretion, thereby lowering circulating hormone levels to effectively manage secondary hyperparathyroidism in patients with chronic kidney disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.