Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease

NCT00261950 | Completed Phase 2 Results

• 3 other identifiers: 20050104BONAFIDE StudyIND #56,010
• Study Type: interventional
• Target: 110
• Locations: 12 countries
• Sites: 55

Brief Summary

The purpose of this study is to evaluate the effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.

Conditions

Secondary Hyperparathyroidism

Keywords

Cinacalcet HCl, Cinacalcet, Amgen (AMG) 073, Sensipar, Mimpara, Calcimimetic

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to End of Study in Bone Formation Rate (BFR)

  Baseline to week 52

Secondary Outcomes (12)

• Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP)

  Baseline to weeks 40-52

• Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP)

  Baseline to weeks 40-52

• Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP)

  Baseline to weeks 40-52

• Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52

  Baseline to week 52

• Percent Change From Baseline in N - Telopeptide (NTx) at Week 52

  Baseline to week 52

Study Arms (1)

Cinacalcet

EXPERIMENTAL

All subjects were enrolled into the single arm to receive Cinacalcet. There was no comparator arm.

Drug: Sensipar (Cinacalcet HCl)

Interventions

Sensipar (Cinacalcet HCl) DRUG

All enrolled subjects receive study medication at a starting dose of 30 mg cinacalcet once daily beginning on day 1. Possible sequential doses are 30 mg, 60mg, 90mg, 120mg, 180 mg taken once daily. During the study, dose adjustment (dose increase/decrease/withholding) is based upon iPTH, serum calcium, and subject safety information. Subjects swallowed tablets whole without biting or chewing. Subjects were dispensed investigational product every 4 weeks starting from Day 1 through to Week 48.

Cinacalcet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• One Intact Parathyroid Hormone (iPTH) determination obtained from the central laboratory must be \>/= 300 pg/mL.
• One serum calcium determination obtained from the central laboratory must be \>/= 8.4 mg/dL (2.1 mmol/L).
• One Bone Alkaline Phosphatase (BALP) determination obtained from the central laboratory must be \>/= 20.9 ng/mL.
• Positive histologic confirmation of high bone turnover disease as assessed by the central bone histology center.
• Treated with dialysis \>/= 1 month before the date of informed consent.

You may not qualify if:

• Have an unstable medical condition in the judgment of the investigator.
• Are pregnant or nursing women.
• Had a parathyroidectomy in the 3 months before the date of informed consent.
• For subjects prescribed vitamin D, have received vitamin D therapy for less than 30 days before day 1 or required a change in vitamin D brand or dose level within 30 days before day 1.
• Ever received therapy with Sensipar®/Mimpara®

Sponsors & Collaborators

• Amgen: lead

Study Sites (55)

Research Site

Phoenix, Arizona, 85012, United States

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Los Angeles, California, 90095, United States

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Denver, Colorado, 80220, United States

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New Haven, Connecticut, 06511, United States

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Fort Lauderdale, Florida, 33334, United States

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Evanston, Illinois, 60201, United States

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New Orleans, Louisiana, 70121, United States

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Baltimore, Maryland, 21205, United States

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St Louis, Missouri, 63110, United States

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Teaneck, New Jersey, 07666, United States

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Flushing, New York, 11355, United States

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Great Neck, New York, 11021, United States

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New York, New York, 10032, United States

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The Bronx, New York, 10467, United States

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Allentown, Pennsylvania, 18103, United States

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Houston, Texas, 77076, United States

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Antwerp, 2020, Belgium

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Antwerp, 2060, Belgium

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Brussels, 1070, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Hradec Králové, 500 05, Czechia

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Prague, 169 00, Czechia

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Budapest, 1083, Hungary

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Debrecen, 4012, Hungary

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Győr, 9023, Hungary

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Miskolc, 3526, Hungary

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Nyíregyháza, 4400, Hungary

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Avellino, 83100, Italy

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Cremona, 26100, Italy

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Genova, 16132, Italy

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Milan, 20162, Italy

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Ortona CH, 66026, Italy

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Ostia RM, 00122, Italy

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Roma, 00149, Italy

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Roma, 00184, Italy

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Roma (RM), 00133, Italy

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Skopje, 1000, North Macedonia

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Krakow, 31-501, Poland

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Lodz, 90-153, Poland

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Wroclaw, 50-556, Poland

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Porto, PR, 4250-499, Portugal

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Almada, 2800-455, Portugal

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Estoril, 2765-294, Portugal

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Guimarães, 4810-273, Portugal

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Porto, 4200-072, Portugal

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Vila Franca de Xira, 2600-076, Portugal

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Santander, Cantabria, 39008, Spain

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Barcelona, Cataluña, 08003, Spain

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Barcelona, Cataluña, 08036, Spain

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Alcorcón, Madrid, 28922, Spain

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Madrid, Madrid, 28046, Spain

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Zurich, 8091, Switzerland

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Izmir, 35360, Turkey (Türkiye)

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Manchester, M13 9WL, United Kingdom

Location

Related Publications (2)

• TBD.BONAFIDE Baseline/Primary Results.Journal-004521;

  BACKGROUND

• Behets GJ, Spasovski G, Sterling LR, Goodman WG, Spiegel DM, De Broe ME, D'Haese PC. Bone histomorphometry before and after long-term treatment with cinacalcet in dialysis patients with secondary hyperparathyroidism. Kidney Int. 2015 Apr;87(4):846-56. doi: 10.1038/ki.2014.349. Epub 2014 Oct 22.

  PMID: 25337774 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2005
• First Posted: December 6, 2005
• Study Start: May 1, 2006
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 21, 2014
• Results First Posted: December 4, 2013

Record last verified: 2014-06

Locations

US (16); PL (3); PT (6); GB (1); ES (5); CH (1); HU (5); CZ (2); IT (9); BE (5); NO (1); TU (1)