To Assess the Long-term Safety of AMG 416 in the Treatment of SHPT in Subjects With CKD on Hemodialysis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02102204
First received: March 3, 2014
Last updated: March 10, 2016
Last verified: March 2016
  Purpose
This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of AMG 416 in the treatment of SHPT in subjects with CKD on hemodialysis.

Condition Intervention Phase
Hyperparathyroidism, Secondary
Drug: AMG 416
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Multicenter Single-arm Extension Study to Describe the Long-term Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Measure the subject incidence of adverse events reported [ Time Frame: 2.5 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measure the occurrence of iPTH value [ Time Frame: months 6, 12, and 18 ] [ Designated as safety issue: No ]
    Within 2x to 9x the upper limit of normal for the assay used

  • Measure the occurrence of Serum phosphorous (P) [ Time Frame: months 6, 12, and 18 ] [ Designated as safety issue: No ]
    Less than or equal to the upper limit of normal for the assay used

  • Assess the nature, frequency, severity, and relationship to treatment of all adverse events reported [ Time Frame: 2.5 Years ] [ Designated as safety issue: Yes ]
  • Occurrence of cCa concentration < 7.5 mg/dL [ Time Frame: months 6, 12, and 18 ] [ Designated as safety issue: Yes ]
  • Assess vital signs, antibody formation to AMG 416, and changes in the laboratory parameters of albumin, total bilirubin (TBL), AST or ALT, and alkaline phosphatase [ Time Frame: 2.5 Years ] [ Designated as safety issue: Yes ]

Enrollment: 902
Study Start Date: March 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 416
Investigational drug product is supplied as a sterile, preservative-free, aqueous solution for injection.
Drug: AMG 416
Subjects will be administered IV AMG 416 at the end of their regular dialysis sessions on a thrice weekly (TIW) schedule. Dose titration is at the discretion of the Investigator and will be based upon the values of the site's contracted laboratory provider iPTH and Ca (cCa, total Ca, or ionized Ca), with the frequency of these laboratory draws at the discretion of each individual Investigator, per standard of care for subjects receiving treatment with a calcimimetic agent. At a minimum however, calcium and albumin must be measured monthly. Subjects entering from the open-label parent studies 20120231 or 20120334 will receive a starting dose of AMG 416 identical to the last dose received in the parent study. Subjects entering from the randomized, double-blind parent Study 20120360, will receive a starting dose of 2.5 mg AMG 416. All subjects will continue to receive AMG 416 until approximately 2.5 years after the first subject enrolls.
Other Name: KAI-4169

Detailed Description:
This is a multicenter, single-arm, extension study in which subjects with secondary hyperparathyroidism currently receiving hemodialysis previously treated in AMG 20120231, 20120334, or 20120360 will continue to be treated with AMG 416. The study will assess the long-term safety and tolerability of AMG 416 as well as measuring the intact parathyroid hormone (iPTH), total serum albumin, corrected calcium (cCa), and serum phosphorous (P) values in these subjects during the course of their treatment.
  Eligibility

Ages Eligible for Study:   18 Years to 110 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has provided informed consent prior to initiation of any study-specific activities/procedures
  • Subject has completed treatment in Study 20120231 (also known as KAI-4169-008) or Study 20120360, or has participated in Study 20120334 (also known as KAI-4169-005-01)
  • Female subjects who are: post menopausal (post menopausal is defined as no menses for the previous 1 year and over the age of 50 years), surgically sterilized, have a medical condition that prevents pregnancy, remain abstinent, or are willing to use an acceptable method of effective contraception during the study and for 3 months after the last dose. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 2 weeks prior to the first dose of AMG 416 in the current study
  • Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months

Exclusion Criteria:

  • Currently receiving treatment in another investigational device or drug study (other than in one of the designated parent studies)
  • Subject has known sensitivity to any of the products or components to be administered during dosing
  • Subject has been prescribed cinacalcet by the primary nephrologist between the conclusion of the parent study and the start of dosing with AMG 416 in the current study
  • Subject is receiving dialysis prescription dialysate calcium concentration < 2.25 mEq/L
  • Subject is pregnant or nursing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02102204

  Show 229 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02102204     History of Changes
Other Study ID Numbers: 20130213  2013-004136-30  KAI-4169 
Study First Received: March 3, 2014
Last Updated: March 10, 2016
Health Authority: Australia: Western Sydney Local Health District Human Research Ethics Committee
Australia: Therapeutic Goods Administration
Austria: Ethikkommission des Landes Oberoesterreich
Austria : AGES Pharm Med
Belgium: Centre Hospitalier Universitaire de Liege - Sart Tilman
Belgium: AZ Delta - Medisch-etische commissie
Belgium: Comite d Ethique Centre Hospitalier Universitaire Brugmann
Belgium: CHwapi-IMC Tournai Comite d Ethique
Belgium: Onze-Lieve-Vrouwziekenhuis Aalst - Ethisch Comite
Belgium: Imelda vzw - Commissie Medische Ethiek
Belgium: Comite d Ethique RHMS Louis Caty
Belgium: Commission d Ethique Biomedicale Hospitalo-Facultaire de l UCL
Belgium: Comite d'Ethique Centre Hospitalier Regional de la Citadelle
Belgium: Jessa Ziekenhuis - Ethische toetsingscommissie
Belgium: Commissie Medische Ethiek van de Universitaire Ziekenhuizen KU Leuven
Belgium: Algemeen Ziekenhuis Groeninge - Ethisch Comite
Belgium : FAGG - AFMPS
Canada: Horizon Health Network REB
Canada: Comite d ethique de la recherche de l Hopital Charles-Le Moyne/CISSS de la Monteregie-Centre
Canada: Health Research Ethics Board
Canada: William Osler Health Centre Research Ethics Board
Canada: University of Alberta, Health Research Ethics Board
Canada: Comite d'ethique de la recherche et de l'evaluation des technologies de la sante
Czech Republic: Eticka Komise Fakultni Nemocnice Hradec Kralove
Czech Republic: Eticka komise pri IKEM a TN
Czech Republic: Eticka komise Nemocnice Novy Jicin as
Czech Republic: Eticka komise Vseobecna fakultni nemocnice v Praze
Czech Republic: Eticka Komise Fakultni Nemocnice Brno
Czech Republic : State Institute for Drug Control (SUKL)
Denmark: Den Videnskabsetiske Komité for Region Hovedstaden
Denmark: Danish Health and Medicines Authority
Estonia : State Agency of Medicines-Ravimiamet
France: Comité de Protection des Personnes Sud-Est I - Hôpital Bellevue
France : ANSM: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Geschäftstelle der Ethikkommission beim Landesamt für Gesundheit
Germany : Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Greece: National Ethics Committee
Greece : National Organization for Medicines (EOF)
Hungary: Egeszsegugyi Tudomanyos Tanacs, Klinikai Farmakologiai Etikai Bizottsaga
Hungary : GYEMSZI Orszagos Gyogyszereszeti Intezet
Italy: Comitato Etico Internazionale delle Province di Lecco, Como e Sondrio
Italy: Comitato Etico Milano Area B IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
Italy: Comitato Etico Regionale IRCCS Ospedale S Martino Istituto Nazionale per la Ricerca sul Cancro
Italy: Comitato Etico Regionale Unico del Friuli AOU Santa Maria della Misericordia di Udine
Italy: Area Vasta Nord Ovest Comitato Etico per la Sperimentazione dei Farmaci AOU Pisana
Italy: Comitato Etico Azienda Ospedaliera Ospedali Riuniti Umberto I Lancisi Salesi
Italy: Area Vasta Centro Comitato Etico per la Sperimentazione Clinica dei Medicinali dell AOU Careggi
Italy: Comitato Etico IRCCS Fondazione Salvatore Maugeri di Pavia
Italy: Comitato Etico per la Sperimentazione Clinica dei Medicinali dell'AOU Integrata di Verona
Italy : AIFA - Italian Medicine Agency Ministry of Health
Latvia: Ethics Committee of Clinical Trials on Medicinal products
Latvia : Latvia State Agency of Medicines
Lithuania: Lithuanian Bioethics Committee
Lithuania : State Medicines Control Agency of Lithuania
Mexico : Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO)
Netherlands: Maasstad Ziekenhuis
Netherlands: Stichting Beoordeling Ethiek Biomedisch Onderzoek
Netherlands: VieCuri Medisch Centrum
Netherlands : Centrale Commissie Mensgebonden Onderzoek (CCMO)
New Zealand: Central Health and Disability Ethics Committee
New Zealand : Medsafe - New Zealand Medicines and Medical Devices Safety Authority
Poland: Komisja Bioetyczna przy Okregowej Izbie Lekarskiej
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal : INFARMED, Autoridade Nacional do Medicamento e Produtos de Saúde I.P.
Russia : Ministry of Health of Russian Federation
Spain: CEIC Hospital Infanta Cristina
Spain: CEIC Regional Comunidad de Madrid
Spain: CEIC Hospital Universitari Arnau de Vilanova de Lleida
Spain: CEIC Hospital de Torrevieja
Spain: CEIC Hospital Universitario Doctor Peset
Spain: CEIC Investigacion Clinica de Navarra
Spain: CEIC Instituto de Investigacion Sanitaria Fundacion Jimenez Diaz
Spain: CEIC Fundacio Puigvert IUNA
Spain: CEIC Hospital Universitari Vall d Hebron
Spain: CEIC de Cantabria
Spain: CEIC Hospital Universitario Reina Sofia
Spain: Comite Coordinador de Etica de la Investigacion Biomedica de Andalucia CCEIBA
Spain: Instituto de Investigacion Hospital 12 de Octubre (i+12)
Spain: CEIC Hospital Clinic i Provincial de Barcelona
Spain: CEIC Parc de Salut Mar
Spain: CEIC Hospital Universitario Puerta de Hierro Majadahonda
Spain : Agencia Española del Medicamento y Productos Sanitarios ( AEMPS)
Sweden: Regionala Etikprövningsnämnden i Stockholm
Sweden : Läkemedelsverket (MPA)
Switzerland: Ethikkommission Nordwest- und Zentralschweiz (EKNZ)
Switzerland: Kantonale Ethikkommission
Switzerland: Commission cantonale d'éthique de la recherche sur l'être humain
Switzerland: Comitatio etico cantonale
Switzerland: Commission centrale d'ethique des Hopitaux Universitaires de Geneve
Switzerland: Kantonale Ethikkommission Bern
Switzerland: Swissmedic
Turkey: Dr Lutfi Kirdar Kartal Egitim ve Arastirma Hastanesi Klinik Arastirmalar Etik Kurulu
Turkey : The Republic of Turkey Ministry of Health -Turkish Drug and Medical Device Institution
United States: Schulman Associates IRB
United States: University of Vermont Research Protections Office
United States: Biomedical Research Alliance of New York LLC
United States: Western Institutional Review Board
United States: NorthShore University HealthSystem Research Institute
United States: Colorado Multiple Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Amgen:
Secondary Hyperparathyroidism (SHPT), chrominc kidney disease (CKD), hemodialysis

Additional relevant MeSH terms:
Neoplasm Metastasis
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 21, 2016