20070360 Incident Dialysis

NCT00803712 | Completed Phase 4 Results

• 1 other identifier: 20070360
• Study Type: interventional
• Target: 313
• Locations: 0 countries
• Sites: N/A

Brief Summary

Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis

Conditions

Chronic Kidney Disease; Secondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

• Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)

  All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For participants with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.

  Weeks 22-26

Secondary Outcomes (29)

• Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)

  Weeks 22-26

• Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)

  Weeks 48-52

• Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)

  Weeks 48-52

• Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)

  Weeks 22-26

• Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)

  Weeks 48-52

Study Arms (2)

Cinacalcet Group

EXPERIMENTAL

Cinacalcet plus low dose active Vitamin D (if prescribed)

Drug: Cinacalcet

Control Group

ACTIVE COMPARATOR

Flexible active vitamin D dosing

Drug: Vitamin D

Interventions

Cinacalcet DRUG

Cinacalcet is a calcimimetic agent, which is synthesized as a hydrochloride salt.

Also known as: Sensipar/Mimpara

Cinacalcet Group

Vitamin D DRUG

Titration of active Vitamin D in accordance with treatment practice guidelines in order to treat Secondary Hyperparathyroidism.

Also known as: Active Vitamin D

Control Group

Eligibility Criteria

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

You may qualify if:

• Adults greater than or equal to 18 years of age on hemodialysis for \> 3 and less than or equal to 12 months prior to enrollment into the study
• Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) \> 300 pg/mL (31.8 pmol/L); or biPTH \> 160 pg/mL (17.0 pmol/L)
• Mean of 2 corrected serum calcium determinations drawn on the same day as the PTH determinations greater than or equal to 8.4 mg/dL (2.1 mmol/L)
• Subject will be able to complete the study, to the best of his/her knowledge
• Before any study-specific procedure, the appropriate written informed consent must be obtained

You may not qualify if:

• Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) \> 800 pg/mL (84.9 pmol/L); or biPTH \> 430 pg/mL (45.6 pmol/L) AND receiving vitamin D on entering screening
• Parathyroidectomy (partial or full) less than or equal to 6 months before entering screening
• Anticipated parathyroidectomy (partial or full) within 6 months after randomization
• Have a scheduled date for kidney transplant surgery
• Received cinacalcet since initiating hemodialysis
• Have received vitamin D therapy for less than 30 days before entering screening or required a change in prescribed vitamin D brand or dose within 30 days before entering screening. If subjects are not receiving vitamin D therapy, they must remain free of vitamin D therapy for the 30 days before entering screening
• Subject is pregnant (eg, positive HCG test) or is breast-feeding
• Refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the study (screening and post enrollment)
• Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets
• Known sensitivity, intolerance, or other adverse response to cinacalcet which would prevent on-study treatment compliance
• Have an unstable medical condition within 30 days before screening, or otherwise unstable in the judgment of the investigator
• Subject is currently enrolled in, or fewer than 30 days prior to entering screening have passed since subject received other investigational agent(s) (devices or drug).

Sponsors & Collaborators

• Amgen: lead

Related Publications (2)

• Rodriguez M, Urena-Torres P, Petavy F, Cooper K, Farouk M, Goodman WG. Calcium-mediated parathyroid hormone suppression to assess progression of secondary hyperparathyroidism during treatment among incident dialysis patients. J Clin Endocrinol Metab. 2013 Feb;98(2):618-25. doi: 10.1210/jc.2012-3246. Epub 2013 Jan 30.

  PMID: 23365129 BACKGROUND

• Urena-Torres P, Bridges I, Christiano C, Cournoyer SH, Cooper K, Farouk M, Kopyt NP, Rodriguez M, Zehnder D, Covic A. Efficacy of cinacalcet with low-dose vitamin D in incident haemodialysis subjects with secondary hyperparathyroidism. Nephrol Dial Transplant. 2013 May;28(5):1241-54. doi: 10.1093/ndt/gfs568. Epub 2013 Jan 16.

  PMID: 23328710 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperparathyroidism, Secondary

Interventions

Cinacalcet; Vitamin D

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Secosteroids; Steroids; Fused-Ring Compounds

Limitations and Caveats

This was an open-label study and neither investigators nor subjects were blinded to treatment modality. Cinacalcet was dosed by forced titration. Active vitamin D administration was at the discretion of the investigator in each treatment arm.

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: November 26, 2008
• First Posted: December 5, 2008
• Study Start: February 1, 2009
• Primary Completion: December 9, 2010
• Study Completion: July 5, 2011
• Last Updated: October 17, 2018
• Results First Posted: March 12, 2014

Record last verified: 2018-09