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NCT06289998
Phase IIa Clinical Trial of Tamibarotene in Patients With Autosomal Dominant Polycystic Kidney Disease
Phase 2 trial testing Tamibarotene in Autosomal Dominant Polycystic Kidney Disease (ADPKD) in 70 participants. Participants enrolled and being followed up; not accepting new ones.
1 December 2025
Quick facts
| Lead sponsor | Rege Nephro Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 22 December 2023 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 8 locations across Japan |
Drugs / interventions tested
- Tamibarotene — full drug profile →
- Placebo
Conditions studied
- Autosomal Dominant Polycystic Kidney Disease (ADPKD) — all drugs for Autosomal Dominant Polycystic Kidney Disease (ADPKD) →
Sponsor
Rege Nephro Co., Ltd.
Who can join
Adults 26 to 55, any sex, with Autosomal Dominant Polycystic Kidney Disease (ADPKD). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Changes in TKV from baseline
Time frame: 52 Week after administration of Investigational Product
TKV
Sponsor's own description
Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Interventions for preventing the progression of autosomal dominant polycystic kidney disease.
St Pierre K, Cashmore BA, Bolignano D, Zoccali C, et al · · 2024 · cited 7× · PMID 39356039 · DOI 10.1002/14651858.cd010294.pub3
Verify or expand the search:
- PubMed search for NCT06289998
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tamibarotene
Trials testing the same drug.
- NCT06085638 — Phase I/II Study of SY-1425 (Tamibarotene) in Combination With Azacitidine and Venetoclax for Patients With Chronic Myel · Phase 1, PHASE2 · withdrawn
- NCT04905407 — Tamibarotene Plus Venetoclax/Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) · Phase 2 · terminated
- NCT04797780 — Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome · Phase 3 · terminated
- NCT02807558 — A Biomarker-Directed Phase 2 Trial of Tamibarotene (SY-1425) in Participants With Acute Myeloid Leukemia or Myelodysplas · Phase 2 · completed
Other recruiting trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Currently open trials in the same condition.
- NCT07161037 — Phase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW) · Phase 2 · recruiting
- NCT06747572 — Polycystic Kidney Disease 1 (PKD1) Gene Variant Groups in Autosomal Dominant Polycystic Kidney Disease · active not recruiting
- NCT07355114 — Robotic vs Open Nephrectomy for ADPKD · active not recruiting
- NCT07535385 — RADIOLOGICAL AND CLINICAL EVALUATION OF RENAL EMBOLIZATION USING EVOH IN DIALYSIS PATIENTS WITH AUTOSOMAL DOMINANT POLYC · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06289998 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rege Nephro Co., Ltd.
- Last refreshed: 3 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06289998.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing