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Secondary HyperparathyroidismPhase 2NCT02133404

A Study to Evaluate the Effect of ASP7991 in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis

A Phase 2 study testing ASP7991 and Cinacalcet in people with Secondary Hyperparathyroidism, run by Astellas Pharma Inc at 6 sites in Japan.

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

To examine efficacy and safety after 12-week administration of ASP7991 in secondary hyperparathyroidism patients undergoing hemodialysis Read more about this study

Who is it for?
Ages 20 to 79 years
Conditions the study is for
Secondary Hyperparathyroidism
What is being tested?
ASP7991 and Cinacalcet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
6 sitesJapan
Study dates
14 Mar 2014to 10 Nov 2014
Phase
Phase 2
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 20 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who are on stable chronic maintenance dialysis who are receiving hemodialysis therapy 3 times/week since before 12-week (84 days) administration and are also scheduled to undergo the regimen of 3 times/week hemodialysis during the study period
  • Patients with secondary hyperparathyroidism
  • Patients whose serum iPTH concentration is >240 pg/mL and corrected serum Ca is ≥ 9.0 mg/dL
  • Patients who have had no changes in the following items ≥4-week (28 days).
  • Dosage and regimen, including new administration, of active vitamin D, calcitonin preparation, phosphate binder, and medication with phosphate absorption (including foods)
  • Ca concentration of the dialysate, membrane area of the dialyzer, and dialysis time of each week

Who cannot join

  • Patients who underwent parathyroid intervention, such as parathyroidectomy (PTx) or percutaneous ethanol injection therapy (PEIT), within 24 weeks (168 days) prior to the administration
  • Patients who have primary hyperparathyroidism
  • Patients who received bisphosphonate, estrogen preparation, parathyroid hormone within 4 weeks (28 days)
  • Patients with uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and diastolic blood pressure ≥ 120 mmHg are observed at >2/3 of all confirmable measurements
  • Patients who are complicated by severe heart disorder [congestive cardiac failure (NYHA classification III or higher), or wide range of old myocardial infarction], or having a history of hospitalization for cerebro-vascular disease or heart disorder within 12 weeks (84 days) before administration of the study drug
  • Patients with hepatic function abnormal (ALT or AST is >2× ULN, or total bilirubin (T-bil) is > 1.5 × ULN.)
Show all 14Show fewer
  • Patients with a history of malignant tumor or the patient's condition is complicated by malignant tumor. (However, enrollment is acceptable if the tumor has not relapsed for 5 years or longer.)
  • Patients with a history of serious drug allergy including anaphylactic shock
  • Patients with a history of drug allergy to Cinacalcet hydrochloride
  • Female patients who are potentially child-bearing or lactating, or patients who do not comply with the instructed contraceptive measures
  • Patients who were or are currently involved in trials for other investigational drugs or medical devices, or clinical trial for post-marketing study drugs within 12 weeks (84 days) before the study
  • Patients who have received ASP7991 in the past
  • Patients who were judged ineligible to participate in the study by the
  • investigator / subinvestigator

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Japan6 sites

  • Study site

    Chūbu

  • Study site

    Chugoku

  • Study site

    Kanto

  • Study site

    Kyushu

  • Study site

    Shikoku

  • Study site

    Tōhoku

Other trials in Japan

About this study

Official title: Phase II Study of ASP7991 -A Double-blind, Cinacalcet Hydrochloride-controlled, Dose-ascending Study in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis -

To examine efficacy and safety after 12-week administration of ASP7991 in secondary hyperparathyroidism patients undergoing hemodialysis

Read the detailed description

This study is a multicenter, double-blind, randomized, Cinacalcet hydrochloride-controlled, parallel-group, dose-ascending study. Subjects judged to be eligible will be registered and randomized into either ASP7991 group (receiving ASP7991 and cinacalcet-placebo) or Cinacalcet group (receiving cinacalcet and ASP7991-placebo), and will receive 12-week (84 days) administration of study drug from first dialysis day in a week (treatment period), in a double-blind manner. The dose of the study drugs will be increased every 3 weeks in dose-ascending manner.

Follow-up assessment will be performed before starting first dialysis in a week, 1 week (7 days) after the completion of the treatment period.

Being tested
ASP7991, Cinacalcet, Placebo
Keywords
Mineral bone disease(MBD), Chronic kidney disease(CKD), secondary hyperparathyroidism(SHPT)
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.

  • ASP7991Drug

    oral

  • CinacalcetDrug

    oral

  • PlaceboDrug

    oral

Study groups in NCT02133404
Study groupRoleWhat they receive
ASP7991 groupExperimentalreceiving ASP7991 and Cinacalcet-placebo
Receives: Drug: ASP7991; Drug: Placebo
Cinacalcet groupActive comparatorreceiving Cinacalcet and ASP7991-placebo
Receives: Drug: Cinacalcet; Drug: Placebo

What is being measured

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

  1. Serum iPTH concentration

    iPTH: intact parathyroid hormone

    Measured: Before and at 8, 15, 22, 24, 29, 36, 43, 45, 50, 57, 64, 66, 71, 78, 85 and 92 days after start of the treatment

Secondary outcomes (6)

  1. Corrected serum Ca, Phosphate(P) concentration

    Ca x P will be calculated

    Measured: Before and at 3, 8, 15, 22, 24, 29, 36, 43, 45, 50, 57, 64, 66, 71, 78, 85 and 92 days after start of the treatment

  2. serum vitamin D concentration

    Measured: Before and at 22, 43, 64, 85 and 92 days after start of the treatment

  3. serum wPTH concentration

    wPTH: whole parathyroid hormone

    Measured: Before and at 22, 43, 64, 85 and 92 days after start of the treatment

  4. Serum concentration of bone metabolism markers

    Bone metabolism markers will be BAP (Bone specific alkaline phosphatase) and TRACP5b (Tartrate-resistant acid phosphatase-5b)

    Measured: Before and at 22, 43, 64, 85 and 92 days after start of the treatment

  5. Serum FGF23 concentration

    Measured: Before and at 22, 43, 64, 85 and 92 days after start of the treatment

  6. Safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs

    Measured: For 12 weeks after start of treatment

Timeline

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

  1. First posted8 May 2014 (estimated)
  2. Study start14 Mar 2014
  3. Primary completion10 Nov 2014
  4. Study completion10 Nov 2014

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02133404
Sponsor's protocol ID
7991-CL-1004
Status last verified
Oct 2024
First submitted
29 Apr 2014
Last updated
6 Nov 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ASP7991 and Cinacalcet in people with Secondary Hyperparathyroidism, run by Astellas Pharma Inc at 6 sites in Japan.

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

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. 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 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Serum iPTH concentration (time frame: Before and at 8, 15, 22, 24, 29, 36, 43, 45, 50, 57, 64, 66, 71, 78, 85 and 92 days after start of the treatment). 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 NCT02133404.

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 6 Nov 2024.

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