Not yet recruitingNCT07891364Updated Oct 23, 2026

GBP-213 in Patients With Autosomal Dominant Polycystic Kidney Disease

An Early Phase 1 interventional study of GBP-213 in Autosomal Dominant Polycystic Kidney, sponsored by RenJi Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by RenJi Hospital · Early Phase 1, Interventional, and Treatment

Updated Oct 23, 2026Newly registeredGo to Updates ↓

Phase: Early Phase 1
Study type: Interventional
Enrollment: 24
Allocation: Non-randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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).

Conditions studied

Autosomal Dominant Polycystic Kidney

Browse trials for

Polycystic Kidney, Autosomal Dominant 177

In context

Polycystic Kidney, Autosomal Dominant

177 studies on the registry are indexed under Polycystic Kidney, Autosomal Dominant; 39 are open to participants now.

This study's planned enrollment of 24 is below the median of 51 across 132 interventional studies indexed under Polycystic Kidney, Autosomal Dominant.

Browse Polycystic Kidney, Autosomal Dominant studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 550 studies on the registry; 248 are open to participants now.

Browse RenJi Hospital studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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.

Study design

Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 24 participants (estimated)

Study arms

Experimental
GBP-213 Dose Escalation dose 1
GBP-213 subcutaneous injection
Drug: GBP-213
Experimental
GBP-213 Dose Expansion dose 2
GBP-213 subcutaneous injection
Drug: GBP-213
Experimental
GBP-213 Dose Escalation dose 3
GBP-213 subcutaneous injection
Drug: GBP-213
Experimental
GBP-213 Dose Escalation dose 4
GBP-213 subcutaneous injection
Drug: GBP-213

Interventions

DrugGBP-213
Subcutaneous injection

What researchers measure

Primary outcomes

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
Time frame: From first treatment (Week 1, Day 1) to 12 months after the last dose (Week 13, Day 1)

Secondary outcomes

Area under the plasma concentration-time curve from time zero to the last measurable time point (AUC0-t)
Time frame: 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-∞)
Time frame: From first dose (Week 1, Day 1) to the last dose (Week 13, Day 1)
Maximum plasma concentration (Cmax)
Time frame: From first dose (Week 1, Day 1) to the last dose (Week 13, Day 1)
Time to maximum plasma concentration (Tmax)
Time frame: From first dose (Week 1, Day 1) to the last dose (Week 13, Day 1)
Terminal elimination half-life (t1/2z)
Time frame: From first dose (Week 1, Day 1) to the last dose (Week 13, Day 1)
Apparent clearance (CLz)
Time frame: From first dose (Week 1, Day 1) to the last dose (Week 13, Day 1)
Apparent volume of distribution (Vz)
Time frame: From first dose (Week 1, Day 1) to the last dose (Week 13, Day 1)

Study locations

1 site

Department of nephrology , Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality 200127, China
- Leyi Gu, Dr. · Contact · guleyi@aliyun.com · 13918148433
- Leyi Gu, Dr. · Principal investigator

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Jul 2027, 8 months later.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 7, 2026
First posted: Oct 23, 2026
StartEst.: Nov 2026
Primary completionEst.: Jul 2027
CompletionEst.: Dec 2028
Last update: Oct 23, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Registered

First appeared on the registry. No changes since

Oct 23, 2026

Show all 1 update

Oct 23, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07891364
Lead sponsor: RenJi Hospital
Responsible party: Sponsor
First posted: Oct 23, 2026
Start date: Nov 2026 (estimated)
Primary completion: Jul 2027 (estimated)
Completion: Dec 2028 (estimated)
Last update: Oct 23, 2026

Study contacts

Leyi Gu

Contact

guleyi@aliyun.com

86-21-58752345 ext. 5505

Leyi Gu

principal investigator · RenJi Hospital

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Polycystic Kidney, Autosomal Dominant →

Other studies from this sponsor

RenJi Hospital →

Start the discussion