Children Under 18 Years Old With Kidney DiseasePhase 3NCT03345316
Study of FFI-1010 in Pediatric Kidney Disease
A Phase 3 study testing FFI-1010 in people with Children Under 18 Years Old With Kidney Disease, run by Fuji Yakuhin Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is revealing that the ratio of creatinine clearance (Ccr) to inulin clearance (Cin) measuring at the same time is more than 1.2. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Children Under 18 Years Old With Kidney Disease
- What is being tested?
- FFI-1010
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- 1 Nov 2017to 1 Nov 2019
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Kidney disease patients requiring exact evaluation of kidney function
- eGFR: >=30 and <=89 mL/min/1.73m^2
Who cannot join
- Edema on the day before start of study treatment
- Oliguria on the day before start of study treatment
- Dehydration on the day before start of study treatment
- Infection or inflammatory disease before administration
- History of epilepsy or organic brain disorder
- History of, clinically significant cardiac, hematologic, hepatic and pancreatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Usability Evaluation Study of FFI-1010 Single Administration for Children Under 18 Years Old With Kidney Disease (Phase III Study).
The purpose of this study is revealing that the ratio of creatinine clearance (Ccr) to inulin clearance (Cin) measuring at the same time is more than 1.2.
- Being tested
- FFI-1010
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFI-1010Drug
Intravenous single dosing
| Study group | Role | What they receive |
|---|---|---|
| FFI-1010 | Experimental | Not described Receives: Drug: FFI-1010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Cin to Ccr measuring at the same time
Demonstrating usability of inulin clearance by comparison between inulin clearance and creatinine clearance at the same time after the start of FFI-1010 administration
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Nov 2017
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
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 Children Under 18 Years Old With Kidney DiseaseStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuji Yakuhin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345316
- Sponsor's protocol ID
- FFI-1010-004
- Status last verified
- Dec 2019
- First submitted
- 13 Nov 2017
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Uemura O, Ishikura K, Kamei K, Hamada R, Yamamoto M, Gotoh Y, Fujita N, Sakai T, Sano T, Fushimi M, Iijima K. Comparison of inulin clearance with 2-h creatinine clearance in Japanese pediatric patients with renal disease: open-label phase 3 study of inulin. Clin Exp Nephrol. 2022 Feb;26(2):132-139. doi: 10.1007/s10157-021-02133-5. Epub 2021 Sep 25.
PubMed 34562149
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Usability Evaluation Study of FFI-1010 Single Administration for Children Under 18 Years Old With Kidney Disease (Phase III Study).
- ClinicalTrials.gov ID
- NCT03345316
- Acronym / sponsor ID
- FFI-1010-004
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fuji Yakuhin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 17 Nov 2017 (actual)
- 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 revealing that the ratio of creatinine clearance (Ccr) to inulin clearance (Cin) measuring at the same time is more than 1.2.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FFI-1010 | Experimental | Drug: FFI-1010 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Kidney disease patients requiring exact evaluation of kidney function
- eGFR: >=30 and <=89 mL/min/1.73m^2
Key exclusion criteria (6 listed)
- Edema on the day before start of study treatment
- Oliguria on the day before start of study treatment
- Dehydration on the day before start of study treatment
- Infection or inflammatory disease before administration
- History of epilepsy or organic brain disorder
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 |
|---|---|---|
| FFI-1010Intravenous single dosing | Drug | FFI-1010 |
Primary outcome
Ratio of Cin to Ccr measuring at the same time
Time frame: 120 minutes
Demonstrating usability of inulin clearance by comparison between inulin clearance and creatinine clearance at the same time after the start of FFI-1010 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 11 Dec 2019.
- Derived from this study: PubMed 34562149Uemura O, Ishikura K, Kamei K, Hamada R, Yamamoto M, Gotoh Y, Fujita N, Sakai T, Sano T, Fushimi M, Iijima K. Comparison of inulin clearance with 2-h creatinine clearance in Japanese pediatric patients with renal disease: open-label phase 3 study of inulin. Clin Exp Nephrol. 2022 Feb;26(2):132-139. doi: 10.1007/s10157-021-02133-5. Epub 2021 Sep 25.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FFI-1010 in people with Children Under 18 Years Old With Kidney Disease, run by Fuji Yakuhin Co., Ltd. at 1 site 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 2 inclusion and 6 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 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Ratio of Cin to Ccr measuring at the same time (time frame: 120 minutes). 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 NCT03345316, 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 11 Dec 2019.