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

  • STATUS
    Recruiting
  • days left to enroll
    80
  • participants needed
    125
  • sponsor
    Goldfinch Bio, Inc.
Updated on 12 August 2021
diabetes
type 2 diabetes mellitus
hba1c
glycated hemoglobin
glomerular filtration rate
angiotensin
nephropathy
hemoglobin a1c
glycosylated hemoglobin
type 2 diabetes
genetic testing
type 1 diabetes mellitus
mammogram
angiotensin converting enzyme
diabetic nephropathy
glomerulosclerosis
minimal change disease
angiotensin-converting enzyme
focal segmental glomerulosclerosis
segmental glomerulosclerosis

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).

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.

Details
Condition Endocrine disorder, Diabetic Nephropathy, Diabetes Mellitus, diabetic complication, URINARY TRACT DISORDER, Nephrotic Syndrome, Nephrosis, Nephropathy, Focal glomerulosclerosis, Glomerulonephritis, Lipoid nephrosis, Nephritis, Diabetes Prevention, Diabetes Mellitus Types I and II, Kidney Disease (Pediatric), Diabetes (Pediatric), Kidney Disease, Diabetic Kidney Disease, Focal Segmental Glomerulosclerosis, uropathy, diabetic complications, minimal change disease, renal disease, kidney diseases, kidney disorders, nephrologic disease, kidney disorder, disease, kidney, nephritides, diabetes mellitus (dm), endocrinopathy, endocrine disorders, endocrine disease, endocrine diseases, urinary tract disorders, urinary tract disease, urological disease, urological diseases
Treatment Placebo, GFB-887
Clinical Study IdentifierNCT04387448
SponsorGoldfinch Bio, Inc.
Last Modified on12 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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

Exclusion Criteria

All patients
Evidence of another (non-DN, non-FSGS/TR-MCD, respectively) kidney disease
Body mass index (BMI) >40 kg/m2
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
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
Known history of severe or chronic hepatobiliary disease
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