---
title: Study of Tamibarotene in Patients With ADPKD
nct_id: NCT06289998
overall_status: ACTIVE_NOT_RECRUITING
phase: PHASE2
sponsor: Rege Nephro Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
countries: Japan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06289998.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06289998"
ct_last_update_post_date: 2025-04-04
last_seen_at: "2026-05-12T06:37:25.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study of Tamibarotene in Patients With ADPKD

**Official Title:** Phase IIa Clinical Trial of Tamibarotene in Patients With Autosomal Dominant Polycystic Kidney Disease

**NCT ID:** [NCT06289998](https://clinicaltrials.gov/study/NCT06289998)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 70
- **Lead Sponsor:** Rege Nephro Co., Ltd.
- **Conditions:** Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- **Start Date:** 2023-12-22
- **Completion Date:** 2025-12
- **CT.gov Last Update:** 2025-04-04

## Brief Summary

Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease

## Eligibility

- **Minimum age:** 26 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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:

  1. Female: From informed consent to 2 years after the last administration of the study drug
  2. 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
```

## Arms

- **Tamibarotene Group** (ACTIVE_COMPARATOR)
- **Placebo Group** (PLACEBO_COMPARATOR)

## Interventions

- **Tamibarotene** (DRUG) — Subjects are administrated to tamibarotene 4 mg in daily for 52 weeks.
- **Placebo** (DRUG) — Subjects are administrated to placebo in daily for 52 weeks.

## Primary Outcomes

- **Changes in TKV from baseline** _(time frame: 52 Week after administration of Investigational Product)_ — TKV

## 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)_

## Locations (8)

- Kurume University Hospital, Kurume, Fukuoka, Japan
- Hokkaido University Hospital, Sapporo, Hokkaido, Japan
- Shonan Kamakura General Hospital, Kamakura, Kanagawa, Japan
- Toranomon Hospital Kajigaya, Kawasaki, Kanagawa, Japan
- Kyoto University Hospital, Kyoto, Kyoto, Japan
- Juntendo University School of Medicine Juntendo Hospital, Bunkyo-ku, Tokyo, Japan
- Toranomon Hospital, Minato-ku, Tokyo, Japan
- Tokyo Women's Medical University Hospital, Shinjukuku, Tokyo, Japan

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.kurume university hospital|kurume|fukuoka|japan` — added _(2026-05-12)_
- `locations.hokkaido university hospital|sapporo|hokkaido|japan` — added _(2026-05-12)_
- `locations.shonan kamakura general hospital|kamakura|kanagawa|japan` — added _(2026-05-12)_
- `locations.toranomon hospital kajigaya|kawasaki|kanagawa|japan` — added _(2026-05-12)_
- `locations.kyoto university hospital|kyoto|kyoto|japan` — added _(2026-05-12)_
- `locations.juntendo university school of medicine juntendo hospital|bunkyo-ku|tokyo|japan` — added _(2026-05-12)_
- `locations.toranomon hospital|minato-ku|tokyo|japan` — added _(2026-05-12)_
- `locations.tokyo women's medical university hospital|shinjukuku|tokyo|japan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06289998.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06289998*  
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