Autosomal Dominant Polycystic Kidney Disease (ADPKD)Phase 2NCT06289998
Study of Tamibarotene in Patients With ADPKD
A Phase 2 study testing Tamibarotene in people with Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by Rege Nephro Co., Ltd. at 8 sites in Japan.
Trial summary
Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease Read more about this study
- Who is it for?
- Ages 26 to 55 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- What is being tested?
- Tamibarotene
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 8 sitesJapan
- Study dates
- 22 Dec 2023to Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 26 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed as ADPKD by modified Pei-Ravine
- eGFR(CKD-EPI) is equal to or greater than 60 mL/min/1.73m^2
- Patients who are judged to be hard to treat with tolvaptan or who do not wish to be treated with tolvaptan, at the time of obtaining consent
- Patients with systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg. For patients receiving angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists, the dose must be constant for at least 6 weeks before obtaining informed consent
Who cannot join
- Women who are pregnant or may be pregnant
- Nursing mother
- Females with childbearing potential or male subjects with a fertile partner who is unable to use contraception for the following periods:
- Female: From informed consent to 2 years after the last administration of the study drug
- Male: From informed consent to 6 months after the last administration of the study drug
- Patients within 12 weeks from the last dose of a drug that affects renal cysts, such as tolvaptan, to the first dose of the study drug
- Patients with complications of intracranial aneurysm, malignant tumor, uncontrolled diabetes, osteoporosis, uncontrolled dyslipidemia, or abnormal liver function
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Juntendo University School of Medicine Juntendo Hospital
Bunkyo-ku, Tokyo, 113-8431
Shonan Kamakura General Hospital
Kamakura, Kanagawa, 247-8533
Toranomon Hospital Kajigaya
Kawasaki, Kanagawa, 213-8587
Kurume University Hospital
Kurume, Fukuoka, 830-0011
Kyoto University Hospital
Kyoto, Kyoto, 606-8507
Toranomon Hospital
Minato-ku, Tokyo, 105-8470
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Tokyo Women's Medical University Hospital
Shinjukuku, Tokyo, 162-8666
About this study
Official title: Phase IIa Clinical Trial of Tamibarotene in Patients With Autosomal Dominant Polycystic Kidney Disease
Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease
- Being tested
- Tamibarotene, Placebo
- Keywords
- Autosomal dominant polycystic kidney disease
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamibaroteneDrug
Subjects are administrated to tamibarotene 4 mg in daily for 52 weeks.
PlaceboDrug
Subjects are administrated to placebo in daily for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tamibarotene Group | Active comparator | Not described Receives: Drug: Tamibarotene |
| Placebo Group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in TKV from baseline
TKV
Measured: 52 Week after administration of Investigational Product
Secondary outcomes (3)
Changes in TLV from baseline
TLV
Measured: 52 Week after administration of Investigational Product
Changes in eGFR from baseline
eGFR
Measured: 52 Week after administration of Investigational Product
Incidence of adverse events
Safety
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start22 Dec 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
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 Autosomal Dominant Polycystic Kidney Disease (ADPKD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rege Nephro Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289998
- Sponsor's protocol ID
- RP014-01
- Status last verified
- Apr 2025
- First submitted
- 18 Feb 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
PubMed 39356039
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Clinical Trial of Tamibarotene in Patients With Autosomal Dominant Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT06289998
- Acronym / sponsor ID
- RP014-01
- Keywords
- Autosomal dominant polycystic kidney disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Rege Nephro Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Mar 2024 (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.
Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamibarotene Group | Active comparator | Drug: Tamibarotene |
| Placebo Group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 26 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients diagnosed as ADPKD by modified Pei-Ravine
- eGFR(CKD-EPI) is equal to or greater than 60 mL/min/1.73m^2
- Patients who are judged to be hard to treat with tolvaptan or who do not wish to be treated with tolvaptan, at the time of obtaining consent
- Patients with systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg. For patients receiving angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists, the dose must be constant for at least 6 weeks before obtaining informed consent
Key exclusion criteria (7 listed)
- Women who are pregnant or may be pregnant
- Nursing mother
- Females with childbearing potential or male subjects with a fertile partner who is unable to use contraception for the following periods:
- Patients within 12 weeks from the last dose of a drug that affects renal cysts, such as tolvaptan, to the first dose of the study drug
- Patients with complications of intracranial aneurysm, malignant tumor, uncontrolled diabetes, osteoporosis, uncontrolled dyslipidemia, or abnormal liver function
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 |
|---|---|---|
| TamibaroteneSubjects are administrated to tamibarotene 4 mg in daily for 52 weeks. | Drug | Tamibarotene Group |
| PlaceboSubjects are administrated to placebo in daily for 52 weeks. | Drug | Placebo Group |
Primary outcome
Changes in TKV from baseline
Time frame: 52 Week after administration of Investigational Product
TKV
3 secondary outcomes
Changes in TLV from baseline
Time frame: 52 Week after administration of Investigational Product
Changes in eGFR from baseline
Time frame: 52 Week after administration of Investigational Product
Incidence of adverse events
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Derived from this study: PubMed 39356039St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamibarotene in people with Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by Rege Nephro Co., Ltd. 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 4 Apr 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes in TKV from baseline (time frame: 52 Week after administration of Investigational Product). 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 NCT06289998, 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 4 Apr 2025.