Phase 3 study for people with Focal Segmental Glomerulosclerosis

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 15 October 2026 Not medical advice

This trial at a glance

Status Recruiting

Phase Phase 3

Sponsor Boehringer Ingelheim

Registry number NCT07220083

Started 16 February 2026 Today 16 October 2026 Estimated completion 27 December 2028

Where this trial is running

Trial sites and the status recorded for each
Site	City	State or country	Status at this site
Concord Repatriation General Hospital	Concord	NSW	Not yet recruiting
Nepean Hospital	Kingswood	NSW	Recruiting
St George Hospital	Kogarah	NSW	Recruiting
The Children's Hospital at Westmead	Westmead	NSW	Not yet recruiting
Royal Brisbane and Women's Hospital	Herston	QLD	Recruiting
Griffith Health	Southport	QLD	Recruiting
Royal Adelaide Hospital	Adelaide	SA	Recruiting
Sunshine Hospital	AT Albans	VIC	Not yet recruiting
Royal Melbourne Hospital	Parkville	VIC	Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice

Who can join

Age 12 Years and over

Sex Anyone, regardless of sex

Healthy volunteers Not accepted

Enrolment target 286

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion criteria:

1. Male or female participants ≥12 years old on the day of signing informed consent/assent (Visit 1)

2. Weight of ≥40 kg at the screening visit (Visit 1)

3. Body mass index (BMI) of ≤40 kg/m² at the screening visit (Visit 1)

4. Participants with a diagnosis prior to the screening visit (Visit 1) of either:

* Biopsy-confirmed primary focal segmental glomerulosclerosis (pFSGS) (based on Investigator's judgement) OR

* Genetic focal segmental glomerulosclerosis (FSGS) resulting from a gain-of-function mutation in the transient receptor potential cation subfamily C member 6 (TRPC6) gene (based on historical genetic test)

5. Urine protein-creatinine ratio (UPCR) ≥1500 mg/g based on the mean of the spot urine sample and first morning void (FMV) urine sample (both assessed by central laboratory) at the screening visit (Visit 1)

6. Estimated glomerular filtration rate (eGFR)

* For adult participants (≥18 years): ≥25 mL/min/1.73 m² (chronic kidney disease epidemiology collaboration (CKD-EPI) formula based on serum cystatin C) at the screening visit (Visit 1)

* For adolescent participants (12 to \<18 years): ≥25 mL/min/1.73 m² based on chronic kidney disease under 25 years (CKiD U25) formula using serum cystatin C at the screening visit (Visit 1) Further inclusion criteria apply.

Exclusion criteria:

1. Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)

2. Clinical or histologic evidence of secondary adaptive or toxic forms of FSGS (based on Investigator's judgement)

3. FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator's judgement)

4. A history of organ transplantation or planned organ transplantation during the course of the trial

5. Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit 1) Further exclusion criteria apply.

Dates on the record

Started 16 February 2026

Estimated completion 27 December 2028

Registry last updated 14 October 2026

Checked by Voxsanity 15 October 2026

Results, publications and the official record

No results are posted on the official record yet.
No publications are listed on the official record yet.
Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.

Sources and dates

ClinicalTrials.gov – the record this page reformats
ClinicalTrials.gov processing date: 14 October 2026.
This page last checked by Voxsanity: 15 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.

Voxsanity

Clinical trials recruiting in Australia, from the public registries · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial, which may be relevant to my care:

Trial: NCT07220083

Sponsor: Boehringer Ingelheim

Phase: Phase 3

Status: Recruiting

Condition: Focal Segmental Glomerulosclerosis

More information: https://clinicaltrials.gov/study/NCT07220083

Eligibility criteria, as the registry published them

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion criteria:

Male or female participants ≥12 years old on the day of signing informed consent/assent (Visit 1)
Weight of ≥40 kg at the screening visit (Visit 1)
Body mass index (BMI) of ≤40 kg/m² at the screening visit (Visit 1)
Participants with a diagnosis prior to the screening visit (Visit 1) of either:
- Biopsy-confirmed primary focal segmental glomerulosclerosis (pFSGS) (based on Investigator's judgement) OR
- Genetic focal segmental glomerulosclerosis (FSGS) resulting from a gain-of-function mutation in the transient receptor potential cation subfamily C member 6 (TRPC6) gene (based on historical genetic test)
Urine protein-creatinine ratio (UPCR) ≥1500 mg/g based on the mean of the spot urine sample and first morning void (FMV) urine sample (both assessed by central laboratory) at the screening visit (Visit 1)
Estimated glomerular filtration rate (eGFR)
- For adult participants (≥18 years): ≥25 mL/min/1.73 m² (chronic kidney disease epidemiology collaboration (CKD-EPI) formula based on serum cystatin C) at the screening visit (Visit 1)
- For adolescent participants (12 to <18 years): ≥25 mL/min/1.73 m² based on chronic kidney disease under 25 years (CKiD U25) formula using serum cystatin C at the screening visit (Visit 1) Further inclusion criteria apply.

Exclusion criteria:

Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)
Clinical or histologic evidence of secondary adaptive or toxic forms of FSGS (based on Investigator's judgement)
FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator's judgement)
A history of organ transplantation or planned organ transplantation during the course of the trial
Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit 1) Further exclusion criteria apply.

A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a registered health practitioner to access unapproved therapeutic goods for individual patients.

Not medical advice. Voxsanity reformats information published by public registries. It does not give medical advice and is not a substitute for talking to your doctor.