Chronic Renal Failure Patients With Hyperphosphataemia Receiving HemodialysisNCT01901107
Post-marketing Surveillance of Kiklin Capsules in Hemodialysis Patients
An observational study of Chronic Renal Failure Patients With Hyperphosphataemia Receiving Hemodialysis, run by Astellas Pharma Inc at 8 sites in Japan.
Trial summary
The purpose of this survey is to evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Renal Failure Patients With Hyperphosphataemia Receiving Hemodialysis
- What is being tested?
- Kiklin capsules
- Type of treatment
- Pill or oral medicine
- How many people
- 1,078 participants
- Where
- 8 sitesJapan
- Study dates
- Jan 2013to Dec 2016
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chronic renal failure patients with hyperphosphataemia receiving hemodialysis
Chronic renal failure patients with hyperphosphataemia receiving hemodialysis
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Study site
Chūbu, Chubu
Study site
Chugoku, Chugoku
Study site
Hokkaido, Hokkaido
Study site
Kantou, Kantou
Study site
Kinki, Kinki
Study site
Kyusyu, Kyusyu
Study site
Shikoku, Shikoku
Study site
Tōhoku, Touhoku
About this study
Official title: Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphataemia Receiving Hemodialysis
The purpose of this survey is to evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.
Read the detailed description
Bixalomer is administered at initial oral dosage of 500 mg three times a day just before a meal. The dosage can be adjusted based on symptoms and serum phosphorus level.
- Being tested
- Kiklin capsules
- Keywords
- Hemodialysis, CKD (chronic kidney disease), ASP1585, Hyperphosphatemia
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kiklin capsulesDrug
Also called ASP1585, ILY101, AMG223, bixalomer
oral
| Study group | Role | What they receive |
|---|---|---|
| Kiklin group | Not described Receives: Drug: Kiklin capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by the incidence of adverse events, physical exam and lab-tests
Measured: for one year
Secondary outcomes (3)
Serum phosphate level
Measured: Baseline and 1, 2, 3, 6, 12 months after administration
Serum calcium level
Measured: Baseline and 1, 2, 3, 6, 12 months after administration
Intact PTH (parathyroid hormone) level
Measured: Baseline and 1, 2, 3, 6, 12 months after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal Failure Patients With Hyperphosphataemia Receiving HemodialysisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,078 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901107
- Sponsor's protocol ID
- KIK001
- Status last verified
- Jan 2017
- First submitted
- 1 Jul 2013
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphataemia Receiving Hemodialysis
- ClinicalTrials.gov ID
- NCT01901107
- Acronym / sponsor ID
- KIK001
- Keywords
- Hemodialysis, CKD (chronic kidney disease), ASP1585, Hyperphosphatemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,078 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Jul 2013 (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 survey is to evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.
Detailed description
Bixalomer is administered at initial oral dosage of 500 mg three times a day just before a meal. The dosage can be adjusted based on symptoms and serum phosphorus level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kiklin group | – | Drug: Kiklin capsules |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chronic renal failure patients with hyperphosphataemia receiving hemodialysis
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 |
|---|---|---|
| Kiklin capsulesAlso: ASP1585, ILY101, AMG223, bixalomeroral | Drug | Kiklin group |
Primary outcome
Safety assessed by the incidence of adverse events, physical exam and lab-tests
Time frame: for one year
3 secondary outcomes
Serum phosphate level
Time frame: Baseline and 1, 2, 3, 6, 12 months after administration
Serum calcium level
Time frame: Baseline and 1, 2, 3, 6, 12 months after administration
Intact PTH (parathyroid hormone) level
Time frame: Baseline and 1, 2, 3, 6, 12 months after administration
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 27 Jan 2017.
- Individual participant dataSharing planned: Undecided
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.
Use Central Contact study director
Astellas Pharma Inc
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Renal Failure Patients With Hyperphosphataemia Receiving Hemodialysis, run by Astellas Pharma Inc at 8 sites in Japan.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
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?
Safety assessed by the incidence of adverse events, physical exam and lab-tests (time frame: for one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2017.