Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis

NCT01181531 | Completed Phase 4 Results

• 2 other identifiers: 20090686PARADIGM
• Study Type: interventional
• Target: 312
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the efficacy of treatment with cinacalcet to manage plasma parathyroid levels as to compared traditional vitamin D therapy, whether given orally or intravenously, among hemodialysis subjects with secondary hyperparathyroidism when the doses are adjusted appropriately to maintain serum calcium and phosphorous levels with currently recommended ranges.

Conditions

Hyperparathyroidism, Secondary

Keywords

Secondary Hyperthyroidism; Hemodialysis; Parathyroid; PARADIGM

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)

  Mean PTH during EAP is defined as the mean of values at study weeks 40, 44, 48 and 52

  Baseline to week 40-52

Secondary Outcomes (2)

• Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP)

  Baseline to week 40-52

• Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)

  week 40-52

Study Arms (2)

Traditional Vitamin D Therapy

ACTIVE COMPARATOR

Drug: Traditional Vitamin D Therapy

Cinacalcet

EXPERIMENTAL

Drug: Cinacalcet

Interventions

Traditional Vitamin D Therapy DRUG

Traditional vitamin D therapy (eg, calcitriol, paricalcitol, alfacalcidol, doxercalciferol), to manage secondary hyperparathyroidism (SHPT) in this study will be administered according to strategies that have been used in clinical practice and that conform to current therapeutic recommendations and available clinical practice guidelines and product labeling.

Traditional Vitamin D Therapy

Cinacalcet DRUG

Subjects randomized to treatment with cinacalcet will receive an initial oral dose of 30 mg once daily. Doses will be titrated incrementally to 60, 90,120, and 180 mg per day based upon periodic measurements of serum calcium and plasma PTH levels. Cinacalcet is formulated as light green tablets in 30, 60, and 90 mg free-based equivalents. Tablets will be 30, 60, and 90 mg, graduated in size, smallest to largest. Combinations of these 3 fixed dosage formulations will be used to achieve the 120 and 180 mg daily doses.

Cinacalcet

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years at screening
• Treated with maintenance hemodialysis 3 times a week for ≥ 3 months prior to screening
• Informed consent provided by the study candidate
• For subjects NOT receiving cinacalcet and/or vitamin D therapy for SHPT within 60 days prior to enrollment: Plasma PTH levels ≥ 450 pg/mL (50 pmol/L) during screening, as obtained from the central laboratory and, Serum corrected total calcium ≥ 8.4 mg/dL (2.1 mmol/L) and \< 10.2 mg/dL (2.55 mmol/L) during screening, as obtained from the central laboratory

You may not qualify if:

• Parathyroidectomy in the 12 weeks before the date of informed consent
• History of seizure within 12 weeks prior to randomization
• Scheduled for kidney transplant
• Parathyroidectomy anticipated within the next 6 months
• Liver function tests \> than 2 x the Upper Limit of Normal
• Prior use of bisphosphonates, or expected to receive bisphosphonates during the trial
• Subject has previously enrolled in this study
• General
• Other investigational procedures are excluded
• Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
• Subject (male or female) is not willing to use highly effective contraception during treatment and for at least one month (women) and 3 months (men) after the end of treatment
• Subject is pregnant or breast feeding, or planning to become pregnant during study or within 1 month after the end of treatment Male subject with a pregnant partner who is not willing to use a condom during treatment and for at least 1 month after the end of treatment
• Subject has known sensitivity or intolerance to any of the protocol required therapies
• Subject will not be available for protocol-required study visits, to the best of the subject and investigator's knowledge
• Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures

Sponsors & Collaborators

• Amgen: lead

Related Publications (2)

• Wetmore JB, Gurevich K, Sprague S, Da Roza G, Buerkert J, Reiner M, Goodman W, Cooper K. A Randomized Trial of Cinacalcet versus Vitamin D Analogs as Monotherapy in Secondary Hyperparathyroidism (PARADIGM). Clin J Am Soc Nephrol. 2015 Jun 5;10(6):1031-40. doi: 10.2215/CJN.07050714. Epub 2015 Apr 22.

  PMID: 25904755 BACKGROUND

• Sprague SM, Wetmore JB, Gurevich K, Da Roza G, Buerkert J, Reiner M, Goodman W, Cooper K. Effect of Cinacalcet and Vitamin D Analogs on Fibroblast Growth Factor-23 during the Treatment of Secondary Hyperparathyroidism. Clin J Am Soc Nephrol. 2015 Jun 5;10(6):1021-30. doi: 10.2215/CJN.03270314. Epub 2015 Apr 14.

  PMID: 25873267 DERIVED

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 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 13, 2010
• Study Start: October 1, 2010
• Primary Completion: July 17, 2012
• Study Completion: August 14, 2012
• Last Updated: October 17, 2018
• Results First Posted: April 25, 2014

Record last verified: 2018-09