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

• Sponsor: Goldfinch Bio, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04387448
• Collaborator: (none)
• Enrollment: 125
• Locations: 76
• Arms: 2
• Anticipated Duration (Months): 24.1
• Patients Per Site: 1.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Kidney Diseases; Diabetic Nephropathies; Glomerulosclerosis, Focal Segmental; Nephrosis, Lipoid; Urologic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glomerulonephritis; Nephritis; Nephrosis	Drug: GFB-887; Drug: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Multiple-ascending, placebo-controlledMultiple-ascending, placebo-controlled
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 28, 2020
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GFB-887 multiple ascending dose (MAD) active GFB-887 active once-daily dosing	Drug: GFB-887; Investigational Medicinal Product (IMP)
Placebo Comparator: GFB-887 MAD placebo GFB-887 placebo once-daily dosing	Drug: Placebo; Matching

Outcome Measures

Primary Outcome Measures

1. Percentage change in Urine Protein-to-Creatinine Ratio (UPCR) [12 weeks]

2. Percentage change in Urine Albumin-to-Creatinine Ratio (UACR) [12 weeks]

Secondary Outcome Measures

1. Proportion of FSGS/TR-MCD patients achieving a modified partial remission [12 weeks]

2. Proportion of FSGS/TR-MCD patients achieving a complete remission [12 weeks]

3. Percentage change in 24-hour urine protein excretion [12 weeks]

4. Percentage change in 24-hour urine albumin excretion [12 weeks]

5. Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 30% of baseline [12 weeks]

6. Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 40% of baseline [12 weeks]

7. Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 50% of baseline [12 weeks]

8. Incidence and severity of adverse events [12 weeks]

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

10. Incidence of clinically significant changes in laboratory parameters [12 weeks]

11. Plasma pharmacokinetics (PK) parameters: maximum observed plasma concentration (Cmax) [12 weeks]

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

13. Plasma PK parameters: area under the plasma concentration-time curve (AUC) [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All patients:

1. Male or female 18-75 years of age, of any race, at the time of signing informed consent.

2. Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 at Screening.

3. Currently receiving an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).

• For DN patients:

1. Diagnosis of type 2 diabetes with glycated hemoglobin (HbA1c) level ≤11% at Screening.

2. UACR ≥ 150 mg/g.

• For FSGS/TR-MCD patients:

1. Diagnosis of FSGS based on either biopsy or genetic testing or TR-MCD based on biopsy.

2. UPCR ≥ 1.0 g/g.

Exclusion Criteria:

• All patients:

1. Evidence of another (non-DN, non-FSGS/TR-MCD, respectively) kidney disease.

2. 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.

3. History of any organ or bone marrow transplant, including kidney grafts.

4. History of alcoholism or drug/chemical abuse within 12 months prior to Screening.

• For DN patients:

1. Renal disease that requires immunosuppressive therapy (currently, or in the past).

2. Body mass index (BMI) >45 kg/m2.

• For FSGS/TR-MCD patients:

1. Currently on calcineurin inhibitors or history of resistance to calcineurin inhibitors.

2. Body mass index (BMI) >40 kg/m2.

3. Known history of severe or chronic hepatobiliary disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35392
2	Aventiv Research - Phoenix	Mesa	Arizona	United States	85210-6041
3	Arizona Kidney Disease & Hypertension Centers (AKDHC)	Scottsdale	Arizona	United States	85258
4	Academic Medical Research Institute (AMRI)	Glendale	California	United States	90022
5	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
6	Amicis Research Center - Business Center Dr	Northridge	California	United States	91324
7	Amicis Research Center - Reseda Blvd	Northridge	California	United States	91324
8	Valley Renal Medical Group	Northridge	California	United States	91324
9	Respire Research - Palm Springs	Palm Springs	California	United States	92262
10	Dr. Malvin Yan Inc.	S. Gate	California	United States	90280
11	North American Research Institute	San Dimas	California	United States	91773
12	Valiance Clinical Research - Tarzana	Tarzana	California	United States	91356
13	Amicis Research Center	Vacaville	California	United States	95687
14	DaVita Mojave Sage Dialysis	Victorville	California	United States	92395-8322
15	University of Colorado Anschutz Medical Campus	Aurora	Colorado	United States	80045
16	Colorado Kidney Care (Denver Nephrology)	Denver	Colorado	United States	80230
17	Western Nephrology - Westminster	Wheat Ridge	Colorado	United States	80033
18	DaVita Hartford North	Hartford	Connecticut	United States	06112
19	Nephrology Associationes, P.A.	Newark	Delaware	United States	19713
20	Prohealth Research Center - Doral	Doral	Florida	United States	33166
21	Clinical Site Partners Leesburg, LLC	Leesburg	Florida	United States	34748
22	Premier Clinical Research Institute	Miami	Florida	United States	33122
23	Kidney & Hypertension Specialists of Miami	Miami	Florida	United States	33150
24	Nephrology Associates of South Miami, PA	Miami	Florida	United States	33173
25	Avanza Medical Research Center	Pensacola	Florida	United States	32503
26	Coastal Nephrology Associates Research Center, LLC	Port Charlotte	Florida	United States	33952
27	Florida Premier Research Institute - Clay Street	Winter Park	Florida	United States	32789
28	Masters of Clinical Research, Inc.	Augusta	Georgia	United States	30909
29	Inova Clinical Trials and Research Center	Tyrone	Georgia	United States	30290
30	Boise Kidney and Hypertension Institute	Meridian	Idaho	United States	83642
31	Research by Design, LLC	Chicago	Illinois	United States	60643
32	Adventist Health Partners	Hinsdale	Illinois	United States	60521
33	Southern Illinois University School of Medicine	Springfield	Illinois	United States	62702
34	University of Iowa College of Public Health	Iowa City	Iowa	United States	52242
35	My Kidney Center, LLC	Manhattan	Kansas	United States	66502
36	Louisiana Kidney Update, LLC	Lafayette	Louisiana	United States	70506
37	Louisiana State University Health Sciences Center - School of Medicine - New Orleans	New Orleans	Louisiana	United States	70112
38	University of Maryland Medical Center	Baltimore	Maryland	United States	21201
39	Tufts Medical Center	Boston	Massachusetts	United States	02111
40	Renal and Transplant Associates of New England, PC	Springfield	Massachusetts	United States	01107
41	University of Michigan	Ann Arbor	Michigan	United States	48109
42	Wayne State University School of Medicine	Detroit	Michigan	United States	48201
43	St. Clair Nephrology	Roseville	Michigan	United States	48066
44	DaVita Clinical Research	Edina	Minnesota	United States	55435
45	University of Minnesota - Center for Pediatric Obesity Medicine	Minneapolis	Minnesota	United States	55414
46	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
47	Nephrology & Hypertension Associates Ltd	Tupelo	Mississippi	United States	38801
48	Clinical Research Consultants	Kansas City	Missouri	United States	64111
49	DaVita Pelican Point Dialysis	Las Vegas	Nevada	United States	89129
50	Sierra Nevada Nephrology Consultants	Reno	Nevada	United States	89511
51	High Desert Nephrology	Gallup	New Mexico	United States	87301
52	Mount Sinai Medical Center	New York	New York	United States	10029
53	Columbia University Medical Center	New York	New York	United States	10032
54	Eastern Nephrology Associates PLLC	New Bern	North Carolina	United States	28562
55	Akron Nephrology Associates, Inc.	Akron	Ohio	United States	44302
56	Cleveland Clinic	Cleveland	Ohio	United States	44195
57	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210
58	Northeast Clinical Research Center	Bethlehem	Pennsylvania	United States	18017
59	Rhode Island Hospital	East Providence	Rhode Island	United States	02915
60	South Carolina Nephrology and Hypertension	Orangeburg	South Carolina	United States	29118
61	Southeast Renal Research Institute	Chattanooga	Tennessee	United States	37404
62	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
63	Texas Tech University Health Sciences Center - Amarillo	Amarillo	Texas	United States	79106
64	Arlington Nephrology, PC	Arlington	Texas	United States	76015
65	Conroe Willis Medical Research	Conroe	Texas	United States	77304
66	Renal Disease Research Institute	Dallas	Texas	United States	75235
67	El Paso Kidney Specialists, PA	El Paso	Texas	United States	79935
68	Xpress Trials LLC	Houston	Texas	United States	77036
69	Prolato Clinical Research Center	Houston	Texas	United States	77054
70	North Texas Kidney Disease Association	Lewisville	Texas	United States	75057-6039
71	Clinical Advancement Center, PLLC	San Antonio	Texas	United States	78212
72	San Antonio Kidney Disease Center Physicians Group, PLLC	San Antonio	Texas	United States	78258
73	Clear Lake Specialties	Webster	Texas	United States	77598
74	Utah Kidney Research Institute	Salt Lake City	Utah	United States	84115
75	Tidewater Kidney Specialists - Riverview	Norfolk	Virginia	United States	23502
76	Providence Medical Research Center	Spokane	Washington	United States	99204

Sponsors and Collaborators

• Goldfinch Bio, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Goldfinch Bio, Inc.
• ClinicalTrials.gov Identifier: NCT04387448
• Other Study ID Numbers: GFB-887-201
• First Posted: May 13, 2020
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Diseases; Diabetic Nephropathies; Nephritis; Glomerulonephritis; Glomerulosclerosis, Focal Segmental; Urologic Diseases; Nephrosis, Lipoid; Nephrosis; Nephrotic Syndrome; Diabetes Mellitus; Endocrine System Diseases; Diabetes Complications

Study Results

No Results Posted as of Mar 31, 2022