Autosomal Dominant Polycystic KidneyEarly Phase 1NCT07891364
GBP-213 in Patients With Autosomal Dominant Polycystic Kidney Disease
A Early Phase 1 study testing GBP-213 in people with Autosomal Dominant Polycystic Kidney, run by RenJi Hospital at 1 site in China.
Trial summary
This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of GBP-213 in patients with autosomal dominant polycystic kidney disease (ADPKD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney
- What is being tested?
- GBP-213
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to Dec 2028
- Phase
- Early Phase 1
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years inclusive at the time of signing the ICF, regardless of sex.
- Clinically diagnosed with ADPKD
- Meets criteria for rapidly progressive ADPKD.
- 100≥eGFR≥30mL/min/1.73m²
- Understands the study procedures and voluntarily signs the written informed consent form.
Who cannot join
- Diagnosis of renal cystic disease due to other causes, such as autosomal recessive polycystic kidney disease, tuberous sclerosis complex, medullary cystic kidney disease, simple renal cysts, acquired cystic kidney disease, etc.
- Other severe or chronic hepatic or renal diseases in addition to ADPKD, such as glomerular or tubulointerstitial disease, end-stage renal disease, viral/alcoholic hepatitis, active autoimmune hepatitis, liver cancer, renal cancer, acute kidney injury, cirrhosis, etc.
- Use of a vasopressin V2 receptor antagonist (e.g., tolvaptan), somatostatin analog (e.g., lanreotide, pasireotide, octreotide), mTOR inhibitor (e.g., everolimus, sirolimus), or any investigational drug within 30 days or 5 half-lives before dosing, whichever is longer.
- Any of the following cardiovascular or cerebrovascular events within 6 months before dosing: myocardial infarction, unstable angina, ventricular arrhythmia, New York Heart Association class III or IV heart failure, stroke, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of nephrology , Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Leyi Gu, Dr., 13918148433, guleyi@aliyun.com
Leyi Gu, Dr.
About this study
Official title: A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of GBP-213 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD).
This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of GBP-213 in patients with autosomal dominant polycystic kidney disease (ADPKD).
- Conditions
- Autosomal Dominant Polycystic Kidney
- Being tested
- GBP-213
- 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.
GBP-213Drug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| GBP-213 Dose Escalation dose 1 | Experimental | GBP-213 subcutaneous injection Receives: Drug: GBP-213 |
| GBP-213 Dose Expansion dose 2 | Experimental | GBP-213 subcutaneous injection Receives: Drug: GBP-213 |
| GBP-213 Dose Escalation dose 3 | Experimental | GBP-213 subcutaneous injection Receives: Drug: GBP-213 |
| GBP-213 Dose Escalation dose 4 | Experimental | GBP-213 subcutaneous injection Receives: Drug: GBP-213 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of GBP-213 in patients with rapidly progressive ADPKD
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and their relationship to the investigational drug
Measured: From first treatment (Week 1, Day 1) to 12 months after the last dose (Week 13, Day 1)
Secondary outcomes (7)
Area under the plasma concentration-time curve from time zero to the last measurable time point (AUC0-t)
Measured: From first dose (Week 1, Day 1) to the last dose (Week 13, Day 1)
Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞)
Measured: From first dose (Week 1, Day 1) to the last dose (Week 13, Day 1)
Maximum plasma concentration (Cmax)
Measured: From first dose (Week 1, Day 1) to the last dose (Week 13, Day 1)
Time to maximum plasma concentration (Tmax)
Measured: From first dose (Week 1, Day 1) to the last dose (Week 13, Day 1)
Terminal elimination half-life (t1/2z)
Measured: From first dose (Week 1, Day 1) to the last dose (Week 13, Day 1)
Apparent clearance (CLz)
Measured: From first dose (Week 1, Day 1) to the last dose (Week 13, Day 1)
Apparent volume of distribution (Vz)
Measured: From first dose (Week 1, Day 1) to the last dose (Week 13, Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Polycystic KidneyStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leyi Gu, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891364
- Sponsor's protocol ID
- HJG-XJ-GBP213-01
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No