Kidney DiseasePhase 3NCT00094484

Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis

A Phase 3 study testing Cinacalcet HCl in people with Kidney Disease and Chronic Kidney Disease, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the efficacy and safety of cinacalcet compared with placebo in patients with stage 3 and 4 Chronic Kidney Disease (CKD). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Disease, Chronic Kidney Disease
What is being tested?: Cinacalcet HCl
How many people: 400 participants
Where: No sites listed yet
Study dates: Oct 2004to not given
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Inclusion Criteria: Chronic Kidney Disease patients not receiving dialysis with: - An iPTH greater than 100 pg/mL [10.6 pmol/L] for subjects with stage 3 CKD or greater than or equal to 160 pg/mL [17.0 pmol/L] for subjects with stage 4 CKD; - A serum calcium greater than 9.0 mg/dL [2.25 mmol/L]; - An estimated GFR less than or equal to 59 mL/min and greater than or equal to 15 mL/min. Exclusion Criteria: - Have an unstable medical condition, defined as having been hospitalized within 30 days before day 1, or otherwise unstable in the judgment of the investigator. - Experienced a myocardial infarction (MI) within 3 months before day 1. - Likely to initiate dialysis (in the opinion of the investigator) or are scheduled to undergo renal transplantation within 28 weeks after day 1. - Received active vitamin D therapy (i.e., 1-hydroxylated metabolites of vitamin D) for less than 30 days before day 1 or required a change in active vitamin D brand or dose level within 30 days before day 1 (for patients prescribed active vitamin D).

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis

The purpose of this study is to evaluate the efficacy and safety of cinacalcet compared with placebo in patients with stage 3 and 4 Chronic Kidney Disease (CKD).

Conditions: Kidney Disease, Chronic Kidney Disease
Being tested: Cinacalcet HCl
Keywords: Sensipar®, Mimpara®, Cinacalcet, Calcimimetic, Chronic Kidney Disease
Medical subject headings: Kidney Diseases, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cinacalcet HClDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks

Secondary outcomes (2)

Changes in iPTH at 32 weeks.
Safety and tolerability of cinacalcet at 32 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2004?

First posted20 Oct 2004 (estimated)
Study startOct 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Kidney DiseaseStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Enrolment: 400 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00094484
Sponsor's protocol ID: 20000178
Status last verified: May 2013
First submitted: 19 Oct 2004
Last updated: 8 May 2013
Results posted: No

Publications

Chonchol M, Locatelli F, Abboud HE, Charytan C, de Francisco AL, Jolly S, Kaplan M, Roger SD, Sarkar S, Albizem MB, Mix TC, Kubo Y, Block GA. A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of cinacalcet HCl in participants with CKD not receiving dialysis. Am J Kidney Dis. 2009 Feb;53(2):197-207. doi: 10.1053/j.ajkd.2008.09.021. Epub 2008 Dec 24.
PubMed 19110359

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Kidney Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis
ClinicalTrials.gov ID: NCT00094484
Acronym / sponsor ID: 20000178
Conditions: Kidney Disease, Chronic Kidney Disease
Keywords: Sensipar®, Mimpara®, Cinacalcet, Calcimimetic, Chronic Kidney Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 400 participants
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: Oct 2004
First posted: 20 Oct 2004 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the efficacy and safety of cinacalcet compared with placebo in patients with stage 3 and 4 Chronic Kidney Disease (CKD).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cinacalcet HCl	Drug	–

Primary outcome

Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks

2 secondary outcomes

Changes in iPTH at 32 weeks.
Safety and tolerability of cinacalcet at 32 weeks.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2013.
Results publication: PubMed 19110359Chonchol M, Locatelli F, Abboud HE, Charytan C, de Francisco AL, Jolly S, Kaplan M, Roger SD, Sarkar S, Albizem MB, Mix TC, Kubo Y, Block GA. A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of cinacalcet HCl in participants with CKD not receiving dialysis. Am J Kidney Dis. 2009 Feb;53(2):197-207. doi: 10.1053/j.ajkd.2008.09.021. Epub 2008 Dec 24.
AmgenTrials clinical trials websiteLink provided by the sponsor.
FDA-approved Drug LabelingLink provided by the sponsor.

Related trials for Kidney Disease

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cinacalcet HCl in people with Kidney Disease and Chronic Kidney Disease, run by Amgen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00094484, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2013.