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Secondary HyperparathyroidismPhase 4NCT00135304

ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism

A Phase 4 study testing Sensipar® and Vitamin D in people with Secondary Hyperparathyroidism, run by Amgen.

Completed

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

Official record
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Trial summary

The purpose of this study is to compare the proportion of chronic kidney disease (CKD) subjects on dialysis receiving Sensipar® and low dose vitamin D or escalating doses of vitamin D alone who are able to achieve the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI) secondary… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Secondary Hyperparathyroidism
What is being tested?
Sensipar® and Vitamin D
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
No sites listed yet
Study dates
Aug 2005to Dec 2006
Phase
Phase 4
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: - On hemodialysis for at least 3 months and have received intravenous vitamin D therapy (paricalcitol or doxercalciferol) for at least 3 months prior to entering screening - Historical iPTH 150-800 pg/ml (or biPTH 80-430 pg/ml) within 6 months and corrected serum Ca greater than 8.4 mg/dl within 2 months prior to screening period. For subjects with biPTH 80-160 pg/ml (iPTH 150-300 pg/ml), Ca x P must be greater than 55 mg²/dl² within 2 months prior to the screening period - Screening (pre-washout) biPTH 80-430 pg/ml and a corrected serum Ca level greater than 8.4 mg/dl. For subjects with biPTH 80-160 pg/ml Ca x P must be also greater than 55 mg²/dl² - Baseline mean biPTH (post-washout) greater than 160 pg/ml and mean corrected Ca greater than 8.4 mg/dl Exclusion Criteria: - Parathyroidectomy in the 3 month period prior to screening - Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets - Use of investigational drug or device or participation in a trial of investigational drug or device within 30 days of screening - Females of child bearing potential who are pregnant (e.g., positive pregnancy test) or are breast feeding or who refuse to use highly effective contraceptive measures (as determined by the investigator) throughout the study - Previously participated in this or any other Sensipar® study or has received or is receiving Sensipar® as a commercially available product

About this study

Official title: ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism: A Comparison of Sensipar® and Low Dose Vitamin D vs. Escalating Doses of Vitamin D Alone

The purpose of this study is to compare the proportion of chronic kidney disease (CKD) subjects on dialysis receiving Sensipar® and low dose vitamin D or escalating doses of vitamin D alone who are able to achieve the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI) secondary hyperparathyroidism (HPT) treatment targets for both biointact parathyroid hormone (biPTH) and calcium-phosphorus (Ca x P) product.

Being tested
Sensipar®, Vitamin D
Keywords
Vitamin D, Sensipar®, Cinacalcet HCl, Chronic Kidney Disease
Medical subject headings
Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic

What participants receive

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

  • Sensipar®Drug

    Also called Cinacalcet hydrochloride, Cinacalcet HCL, Cinacalcet

    Cinacalcet hydrochloride

  • Vitamin DDrug

    Also called paricalcitol, doxercalciferol

    Vitamin D administered IV

Study groups in NCT00135304
Study groupRoleWhat they receive
Cinacalcet and low-dose Vitamin DExperimentalCinacalcet and low-dose IV Vitamin D
Receives: Drug: Sensipar®; Drug: Vitamin D
Vitamin D aloneActive comparatorEscalating doses of IV Vitamin D alone
Receives: Drug: Vitamin D

What is being measured

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

  1. Achieving the NKF-K/DOQI targets for both biPTH (80-160 pg/mL, equivalent to iPTH 150-300 pg/mL) and Ca x P (less than 55 mg^2/dL^2) during the assessment phase

    Proportion of subjects in each treatment group simultaneously achieving the National Kidney Foundation - Kidney Disease Outcome Quality Initiative (NKF-K/DOQI) targets for both biPTH (80-160 pg/mL, equivalent to iPTH 150-300 pg/mL) and Ca x P (< 55 mg^2/dL^2) during the assessment phase (last 11 weeks of study following a 16-week titration phase)

    Measured: Weeks 17 - 27

Secondary outcomes (13)

  1. Absolute Change from Baseline for P During the Assessment Phase

    Absolute change from baseline for serum phosphorus (P) during the assessment phase

    Measured: Baseline to weeks 17-27

  2. Proportion of Participants with ≥ 30% Reduction from Baseline in Mean iPTH During the Assessment Phase

    Proportion of participants with ≥ 30% reduction from baseline in mean intact parathyroid hormone (iPTH) during the assessment phase.

    Measured: Baseline and Weeks 17-27

  3. Percent Change from Baseline for Calcium During the Assessment Phase

    Percent Change from Baseline for Calcium (Ca) During the Assessment Phase

    Measured: Baseline to weeks 17-27

  4. Percent Change from Baseline for Phosphorus During the Assessment Phase

    Percent change from baseline for Phosphorus (P) during the assessment phase

    Measured: Baseline to weeks 17-27

  5. Percent Change from Baseline for Ca x P During the Assessment Phase

    Percent change from baseline for calcium x phosphorus (Ca x P) during the assessment phase

    Measured: Baseline to weeks 17-27

  6. Percent Change from Baseline for iPTH During the Assessment Phase

    Percent change from baseline for intact parathyroid hormone (iPTH) during the assessment phase

    Measured: Baseline to weeks 17-27

  7. Proportion of Participants who Attained the K/DOQI Target Range for Ca x P During the Assessment Phase.

    Proportion of participants who attained the K/DOQI target range for calcium x phosphorus (Ca x P) during the assessment phase.

    Measured: Weeks 17 - 27

  8. Proportion of Participants who Attained the K/DOQI Target Range for Ca During the Assessment Phase

    Proportion of participants who attained the K/DOQI target range for calcium (Ca) during the assessment phase.

    Measured: Weeks 17-27

  9. Proportion of Participants who Attained the K/DOQI Target Range for iPTH During the Assessment Phase

    Proportion of participants who attained the K/DOQI target range for intact parathyroid hormone (iPTH) during the assessment phase.

    Measured: Weeks 17-27

  10. Proportion of Participants who Attained the K/DOQI Target Range for P During the Assessment Phase.

    Proportion of participants who attained the K/DOQI target range for phosphorus (P) during the assessment phase.

    Measured: Weeks 17-27

  11. Absolute Change from Baseline for iPTH During the Assessment Phase

    Absolute change from baseline for intact parathyroid hormone (iPTH) during the assessment phase.

    Measured: Baseline to weeks 17-27

  12. Absolute Change from Baseline for Ca During the Assessment Phase

    Absolute change from baseline for calcium (Ca) during the assessment phase

    Measured: Baseline to weeks 17-27

  13. Absolute Change from Baseline for Ca x P During the Assessment Phase

    Absolute change from baseline for calcium x phosphorus (Ca x P) during the assessment phase.

    Measured: Baseline to weeks 17-27

Timeline

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

  1. First posted26 Aug 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionOct 2006
  4. Study completionDec 2006

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00135304
Sponsor's protocol ID
20050102
Status last verified
Feb 2014
First submitted
24 Aug 2005
Last updated
11 Feb 2014
Results posted
No

Publications

  • Fishbane S, Shapiro WB, Corry DB, Vicks SL, Roppolo M, Rappaport K, Ling X, Goodman WG, Turner S, Charytan C. Cinacalcet HCl and concurrent low-dose vitamin D improves treatment of secondary hyperparathyroidism in dialysis patients compared with vitamin D alone: the ACHIEVE study results. Clin J Am Soc Nephrol. 2008 Nov;3(6):1718-25. doi: 10.2215/CJN.01040308.

    PubMed 18945995

  • Shireman TI, Almehmi A, Wetmore JB, Lu J, Pregenzer M, Quarles LD. Economic analysis of cinacalcet in combination with low-dose vitamin D versus flexible-dose vitamin D in treating secondary hyperparathyroidism in hemodialysis patients. Am J Kidney Dis. 2010 Dec;56(6):1108-16. doi: 10.1053/j.ajkd.2010.07.012. Epub 2010 Oct 15.

    PubMed 20951487

  • TBD.Sensipar plus low dose vitamin D (ACHIEVE).Journal-004521;

  • TBD.Time in target.Journal-004521;

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sensipar® and Vitamin D in people with Secondary Hyperparathyroidism, 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 11 Feb 2014. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Achieving the NKF-K/DOQI targets for both biPTH (80-160 pg/mL, equivalent to iPTH 150-300 pg/mL) and Ca x P (less than 55 mg^2/dL^2) during the assessment phase (time frame: Weeks 17 - 27). 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 NCT00135304, which also lists 4 linked publications.

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 11 Feb 2014.

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