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

Primary Purpose

Hyperparathyroidism, Secondary

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Traditional Vitamin D Therapy

Cinacalcet

About this trial

This is an interventional treatment trial for Hyperparathyroidism, Secondary focused on measuring Secondary Hyperthyroidism, Hemodialysis, Parathyroid, PARADIGM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional Vitamin D Therapy

Cinacalcet

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Number of participants achieving a >=30% Reduction From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)

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

Number of participants achieving Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)

Full Information

NCT ID

NCT01181531

First Posted

August 12, 2010

Last Updated

September 20, 2018

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT01181531

Brief Title

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

Official Title

A Multicenter, Randomized, Open Label Study to Compare the Efficacy of Cinacalcet Versus Traditional Vitamin D Therapy for Management of Secondary Hyperparathyroidism Among Subjects Undergoing Hemodialysis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

October 1, 2010 (Actual)

Primary Completion Date

July 17, 2012 (Actual)

Study Completion Date

August 14, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperparathyroidism, Secondary

Keywords

Secondary Hyperthyroidism, Hemodialysis, Parathyroid, PARADIGM

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

312 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Traditional Vitamin D Therapy

Arm Type

Active Comparator

Arm Title

Cinacalcet

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Traditional Vitamin D Therapy

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Cinacalcet

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline to week 40-52

Secondary Outcome Measure Information:

Title

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

Description

Number of participants achieving a >=30% Reduction From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)

Time Frame

Baseline to week 40-52

Title

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

Description

Number of participants achieving Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)

Time Frame

week 40-52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

25904755

Citation

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.

Results Reference

background

PubMed Identifier

25873267

Citation

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.

Results Reference

derived

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

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

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