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Kidney DiseasesPhase 2NCT04387448

A Study of TRPC5 Channel Inhibitor in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease

A Phase 2 study testing GFB-887 in people with Kidney Diseases and Diabetic Nephropathies, run by Goldfinch Bio, Inc. at 74 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a phase 2a study evaluating the safety and tolerability of multiple ascending doses of GFB-887 in patients with diabetic nephropathy (DN), focal segmental glomerulosclerosis (FSGS), and treatment-resistant minimal change disease (TR-MCD). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
GFB-887
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
74 sitesUnited States
Study dates
28 Jul 2020to 1 Nov 2022
Phase
Phase 2
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients:
  • Male or female 18-75 years of age, of any race, at the time of signing informed consent.
  • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 at Screening.
  • Currently receiving an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).
  • For DN patients:
  • Diagnosis of type 2 diabetes with glycated hemoglobin (HbA1c) level ≤11% at Screening.
Show all 10Show fewer
  • UACR ≥ 150 mg/g.
  • For FSGS/TR-MCD patients:
  • Diagnosis of FSGS based on either biopsy or genetic testing or TR-MCD based on biopsy.
  • UPCR ≥ 1.0 g/g.

Who cannot join

  • All patients:
  • Evidence of another (non-DN, non-FSGS/TR-MCD, respectively) kidney disease.
  • History of malignancy, unless in remission for at least 5 years other than adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or prostate cancer not expected to require treatment over the course of the study.
  • History of any organ or bone marrow transplant, including kidney grafts.
  • History of alcoholism or drug/chemical abuse within 12 months prior to Screening.
  • For DN patients:
Show all 12Show fewer
  • Renal disease that requires immunosuppressive therapy (currently, or in the past).
  • Body mass index (BMI) >45 kg/m2.
  • For FSGS/TR-MCD patients:
  • Currently on calcineurin inhibitors or history of resistance to calcineurin inhibitors.
  • Body mass index (BMI) >40 kg/m2.
  • Known history of severe or chronic hepatobiliary disease.

Trial locations and contacts

74 sites in 1 country.

74 sites in 1 country

United States74 sites

  • Akron Nephrology Associates, Inc.

    Akron, Ohio, 44302

  • Texas Tech University Health Sciences Center - Amarillo

    Amarillo, Texas, 79106

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Arlington Nephrology, PC

    Arlington, Texas, 76015

  • Masters of Clinical Research, Inc.

    Augusta, Georgia, 30909

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Northeast Clinical Research Center

    Bethlehem, Pennsylvania, 18017

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35392

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Southeast Renal Research Institute

    Chattanooga, Tennessee, 37404

  • Research by Design, LLC

    Chicago, Illinois, 60643

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Conroe Willis Medical Research

    Conroe, Texas, 77304

  • Renal Disease Research Institute

    Dallas, Texas, 75235

  • Colorado Kidney Care (Denver Nephrology)

    Denver, Colorado, 80230

  • Wayne State University School of Medicine

    Detroit, Michigan, 48201

  • Prohealth Research Center - Doral

    Doral, Florida, 33166

  • Rhode Island Hospital

    East Providence, Rhode Island, 02915

  • DaVita Clinical Research

    Edina, Minnesota, 55435

  • El Paso Kidney Specialists, PA

    El Paso, Texas, 79935

  • Academic Medical Research Institute (AMRI)

    Glendale, California, 90022

  • Amicis Research Center

    Granada Hills, California, 91344

  • DaVita Hartford North

    Hartford, Connecticut, 06112

  • Adventist Health Partners

    Hinsdale, Illinois, 60521

  • Xpress Trials LLC

    Houston, Texas, 77036

  • Prolato Clinical Research Center

    Houston, Texas, 77054

  • University of Iowa College of Public Health

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Clinical Research Consultants

    Kansas City, Missouri, 64111

  • Louisiana Kidney Update, LLC

    Lafayette, Louisiana, 70506

  • DaVita Pelican Point Dialysis

    Las Vegas, Nevada, 89129

  • Clinical Site Partners Leesburg, LLC

    Leesburg, Florida, 34748

  • North Texas Kidney Disease Association

    Lewisville, Texas, 75057-6039

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • My Kidney Center, LLC

    Manhattan, Kansas, 66502

  • Boise Kidney and Hypertension Institute

    Meridian, Idaho, 83642

  • Aventiv Research - Phoenix

    Mesa, Arizona, 85210-6041

  • Premier Clinical Research Institute

    Miami, Florida, 33122

  • Kidney & Hypertension Specialists of Miami

    Miami, Florida, 33150

  • University of Minnesota - Center for Pediatric Obesity Medicine

    Minneapolis, Minnesota, 55414

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Eastern Nephrology Associates PLLC

    New Bern, North Carolina, 28562

  • Louisiana State University Health Sciences Center - School of Medicine - New Orleans

    New Orleans, Louisiana, 70112

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Nephrology Associationes, P.A.

    Newark, Delaware, 19713

  • Tidewater Kidney Specialists - Riverview

    Norfolk, Virginia, 23502

  • Amicis Research Center

    Northridge, California, 91324

  • Valley Renal Medical Group

    Northridge, California, 91324

  • South Carolina Nephrology and Hypertension

    Orangeburg, South Carolina, 29118

  • Respire Research - Palm Springs

    Palm Springs, California, 92262

  • Avanza Medical Research Center

    Pensacola, Florida, 32503

  • Coastal Nephrology Associates Research Center, LLC

    Port Charlotte, Florida, 33952

  • Sierra Nevada Nephrology Consultants

    Reno, Nevada, 89511

  • St. Clair Nephrology

    Roseville, Michigan, 48066

  • Utah Kidney Research Institute

    Salt Lake City, Utah, 84115

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78212

  • San Antonio Kidney Disease Center Physicians Group, PLLC

    San Antonio, Texas, 78258

  • North American Research Institute

    San Dimas, California, 91773

  • Arizona Kidney Disease & Hypertension Centers (AKDHC)

    Scottsdale, Arizona, 85258

  • Dr. Malvin Yan Inc.

    South Gate, California, 90280

  • Providence Medical Research Center

    Spokane, Washington, 99204

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Renal and Transplant Associates of New England, PC

    Springfield, Massachusetts, 01107

  • Valiance Clinical Research - Tarzana

    Tarzana, California, 91356

  • Nephrology & Hypertension Associates Ltd

    Tupelo, Mississippi, 38801

  • Inova Clinical Trials and Research Center

    Tyrone, Georgia, 30290

  • Amicis Research Center

    Vacaville, California, 95687

  • DaVita Mojave Sage Dialysis

    Victorville, California, 92395-8322

  • Clear Lake Specialties

    Webster, Texas, 77598

  • Western Nephrology - Westminster

    Wheat Ridge, Colorado, 80033

  • Florida Premier Research Institute - Clay Street

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Phase 2a Multiple Ascending, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GFB-887, a TRPC5 Channel Inhibitor, in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease

This is a phase 2a study evaluating the safety and tolerability of multiple ascending doses of GFB-887 in patients with diabetic nephropathy (DN), focal segmental glomerulosclerosis (FSGS), and treatment-resistant minimal change disease (TR-MCD).

Read the detailed description

Approximately 125 patients will be enrolled in this study across the United States. Patients with DN and FSGS/TR-MCD will be randomized in 3 ascending dose cohorts to receive either GFB-887 or placebo.

Being tested
GFB-887, Placebo
Medical subject headings
Kidney Diseases, Diabetic Nephropathies, Glomerulosclerosis, Focal Segmental, Nephrosis, Lipoid, Urologic Diseases, Diabetes Complications, Diabetes Mellitus, Endocrine System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GFB-887Drug

    Investigational Medicinal Product (IMP)

  • PlaceboDrug

    Matching

Study groups in NCT04387448
Study groupRoleWhat they receive
GFB-887 multiple ascending dose (MAD) activeExperimentalGFB-887 active once-daily dosing
Receives: Drug: GFB-887
GFB-887 MAD placeboPlacebo comparatorGFB-887 placebo once-daily dosing
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage change in Urine Protein-to-Creatinine Ratio (UPCR)

    Measured: 12 weeks

  2. Percentage change in Urine Albumin-to-Creatinine Ratio (UACR)

    Measured: 12 weeks

Secondary outcomes (13)

  1. Proportion of FSGS/TR-MCD patients achieving a modified partial remission

    Measured: 12 weeks

  2. Proportion of FSGS/TR-MCD patients achieving a complete remission

    Measured: 12 weeks

  3. Percentage change in 24-hour urine protein excretion

    Measured: 12 weeks

  4. Percentage change in 24-hour urine albumin excretion

    Measured: 12 weeks

  5. Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 30% of baseline

    Measured: 12 weeks

  6. Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 40% of baseline

    Measured: 12 weeks

  7. Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 50% of baseline

    Measured: 12 weeks

  8. Incidence and severity of adverse events

    Measured: 12 weeks

  9. Incidence of clinically significant changes in 12-lead electrocardiogram (ECG) parameters, vital signs measurements, and physical examinations

    Measured: Approximately 12 weeks

  10. Incidence of clinically significant changes in laboratory parameters

    Measured: 12 weeks

  11. Plasma pharmacokinetics (PK) parameters: maximum observed plasma concentration (Cmax)

    Measured: 12 weeks

  12. Plasma PK parameters: time of the observed plasma concentration (Tmax)

    Measured: 12 weeks

  13. Plasma PK parameters: area under the plasma concentration-time curve (AUC)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2020
  2. Study start28 Jul 2020
  3. Primary completion1 Nov 2022
  4. Study completion1 Nov 2022

Why it stopped: Business reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multiple-ascending, placebo-controlled
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04387448
Sponsor's protocol ID
GFB-887-201
Status last verified
Nov 2022
First submitted
11 May 2020
Last updated
15 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GFB-887 in people with Kidney Diseases and Diabetic Nephropathies, run by Goldfinch Bio, Inc. at 74 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change in Urine Protein-to-Creatinine Ratio (UPCR) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04387448.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.

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