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

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ClinicalTrials.gov Identifier: NCT04387448
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Goldfinch Bio, Inc.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multiple-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 : July 28, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021


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




Primary Outcome Measures :
  1. Percentage change in Urine Protein-to-Creatinine Ratio (UPCR) [ Time Frame: 12 weeks ]
  2. Percentage change in Urine Albumin-to-Creatinine Ratio (UACR) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Proportion of FSGS/TR-MCD patients achieving a modified partial remission [ Time Frame: 12 weeks ]
  2. Proportion of FSGS/TR-MCD patients achieving a complete remission [ Time Frame: 12 weeks ]
  3. Percentage change in 24-hour urine protein excretion [ Time Frame: 12 weeks ]
  4. Percentage change in 24-hour urine albumin excretion [ Time Frame: 12 weeks ]
  5. Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 30% of baseline [ Time Frame: 12 weeks ]
  6. Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 40% of baseline [ Time Frame: 12 weeks ]
  7. Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 50% of baseline [ Time Frame: 12 weeks ]
  8. Incidence and severity of adverse events [ Time Frame: 12 weeks ]
  9. Incidence of clinically significant changes in 12-lead electrocardiogram (ECG) parameters, vital signs measurements, and physical examinations [ Time Frame: Approximately 12 weeks ]
  10. Incidence of clinically significant changes in laboratory parameters [ Time Frame: 12 weeks ]
  11. Plasma pharmacokinetics (PK) parameters: maximum observed plasma concentration (Cmax) [ Time Frame: 12 weeks ]
  12. Plasma PK parameters: time of the observed plasma concentration (Tmax) [ Time Frame: 12 weeks ]
  13. Plasma PK parameters: area under the plasma concentration-time curve (AUC) [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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) ≥ 45 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 ≤10% 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. Body mass index (BMI) >40 kg/m2.
    3. 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.
    4. History of any organ or bone marrow transplant, including kidney grafts.
    5. 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).

  • For FSGS/TR-MCD patients:

    1. Currently on calcineurin inhibitors or history of resistance to calcineurin inhibitors.
    2. Known history of severe or chronic hepatobiliary disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04387448


Contacts
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Contact: Goldfinch Bio Clinical Trials Information (617) 337-4000 clinicaltrials@goldfinchbio.com

Locations
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Sponsors and Collaborators
Goldfinch Bio, Inc.
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Responsible Party: Goldfinch Bio, Inc.
ClinicalTrials.gov Identifier: NCT04387448    
Other Study ID Numbers: GFB-887-201
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Nephritis
Glomerulonephritis
Glomerulosclerosis, Focal Segmental
Urologic Diseases
Nephrosis, Lipoid
Nephrosis
Nephrotic Syndrome
Diabetes Mellitus
Endocrine System Diseases
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases