Chronic Renal FailureNCT01903213
Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphatemia Receiving Peritoneal Dialysis
An observational study of Chronic Renal Failure, run by Astellas Pharma Inc at 8 sites in Japan.
Trial summary
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
- What is being tested?
- bixalomer
- Type of treatment
- Pill or oral medicine
- How many people
- 123 participants
- Where
- 8 sitesJapan
- Study dates
- 19 Mar 2013to 31 Dec 2019
- 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: Patients with Chronic renal failure with Hyperphosphatemia receiving Peritoneal dialysis
Who may be able to join
- Chronic renal failure patients with Hyperphosphatemia receiving peritoneal dialysis
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Study site
Chūbu
Study site
Chugoku
Study site
Hokkaido
Study site
Kansai
Study site
Kanto
Study site
Kyushu
Study site
Shikoku
Study site
Tōhoku
About this study
To evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.
- Conditions
- Chronic Renal Failure
- Being tested
- bixalomer
- Keywords
- Peritoneal dialysis, Bixalomer, Chronic renal failure patients with Hyperphosphatemia, Kiklin®
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bixalomerDrug
Also called Kiklin, ASP1585, AMG223, ILY101
Oral
| Study group | Role | What they receive |
|---|---|---|
| Kiklin group | Oral Receives: Drug: bixalomer |
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 (including adverse drug reactions), vital signs and laboratory tests
Measured: Baseline and 1, 2, 3, 6, 12 months after administration
Secondary outcomes (4)
Serum phosphorous levels
Measured: Baseline and 1, 2, 3, 6, 12 months after administration
Serum albumin 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
Serum 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 posted19 Jul 2013 (estimated)
- Study start19 Mar 2013
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies 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
- 123 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
- NCT01903213
- Sponsor's protocol ID
- KIK002
- Status last verified
- Mar 2020
- First submitted
- 17 Jul 2013
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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/.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. 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 Hyperphosphatemia Receiving Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT01903213
- Acronym / sponsor ID
- KIK002
- Conditions
- Chronic Renal Failure
- Keywords
- Peritoneal dialysis, Bixalomer, Chronic renal failure patients with Hyperphosphatemia, Kiklin®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2013 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 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.
To evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kiklin group | – | Drug: bixalomerOral |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Chronic renal failure with Hyperphosphatemia receiving Peritoneal dialysis
Key inclusion criteria (1 listed)
- Chronic renal failure patients with Hyperphosphatemia receiving peritoneal dialysis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| bixalomerAlso: Kiklin, ASP1585, AMG223, ILY101Oral | Drug | Kiklin group |
Primary outcome
Safety assessed by the incidence of adverse events (including adverse drug reactions), vital signs and laboratory tests
Time frame: Baseline and 1, 2, 3, 6, 12 months after administration
4 secondary outcomes
Serum phosphorous levels
Time frame: Baseline and 1, 2, 3, 6, 12 months after administration
Serum albumin 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
Serum 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 22 Oct 2024.
- Individual participant dataSharing planned: 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/.
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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, 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.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 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 22 Oct 2024. 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 (including adverse drug reactions), vital signs and laboratory tests (time frame: Baseline and 1, 2, 3, 6, 12 months after administration). 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 22 Oct 2024.