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Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants With CKD and Anemia

Primary Purpose

Chronic Kidney Diseases, Anemia of Chronic Kidney Disease

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DISC-0974
Placebo
Sponsored by
Disc Medicine, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Chronic Kidney Disease, Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Aged ≥18 years of age at the time of signing informed consent. Non-dialysis dependent chronic kidney disease, stages 2-5, defined as eGFR <90 mL/min/1.73m2 using the 2021 CKD-EPI formula Women: Hemoglobin <10.5 g/dL; Men: Hemoglobin <11.0 g/dL Serum ferritin ≥100 μg/L at Screening Transferrin saturation ≤35% Body mass index (BMI) of 18.5 to 45.0 kg/m2, inclusive, at screening Aspartate aminotransferase (AST) and alanine transaminase (ALT) <2× upper limit of normal (ULN) at Screening. Total and direct bilirubin <ULN at Screening. Exclusion Criteria: Treatment within 2 days prior to screening with oral iron or iron-containing supplements. Participants may be considered for the study if they undergo a 2-day washout period prior to signing the informed consent form (ICF) and screening for oral iron or iron-containing supplements. Treatment within 30 days prior to screening with one of the following anemia treatments: erythropoietin-stimulating agent or IV iron. Participants may be considered for the study if they undergo a 30-day washout period prior to signing the informed consent form (ICF) and screening for erythropoietin-stimulating agent or IV iron. Acute dialysis or acute kidney injury within 12 weeks prior to screening or expected need to start dialysis within 12 weeks of screening. Hospitalization for a cardiovascular, renal, or cardiorenal condition within 30 days prior to screening. Positive direct antiglobulin test with reactive eluate at screening or active hemolytic anemia. History of hereditary hemochromatosis. History of hemoglobinopathy or intrinsic red blood cell defect associated with anemia. History of total splenectomy. Hematopoietic stem cell or solid organ transplant within the past 10 years. Medical history of anemia from Vitamin B12 or folate deficiency, infection, or bleeding in the 3 months prior to screening Blood transfusion within 3 months of screening Stroke, myocardial infarction, deep venous thrombosis, pulmonary or arterial embolism within 6 months prior to Screening If female, pregnant or breastfeeding. Any major surgery within 8 weeks before Screening or incomplete recovery from any previous surgery. History of malignancy within the last 3 years. The following history/concurrent conditions are allowed: basal or squamous cell carcinoma, carcinoma in situ of the cervix, carcinoma in situ of the breast, histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system). A history of completed treatment (medical or surgical) of Stage 1-2 cancers may be permitted with prior Sponsor agreement. Participation in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices within 30 days of Screening A history or known allergic reaction to any investigational product excipients or history of anaphylaxis to any food or drug History of anti-drug antibody formation History of inadequately controlled heart disease (New York Heart Association Classification 3 or 4) and/or have a history of left ventricular ejection fraction <35% Uncontrolled fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement, despite appropriate treatment) Human immunodeficiency virus positive, active Hepatitis B, or active Hepatitis C. Uncontrolled diabetes mellitus or diabetes mellitus requiring initiation of insulin therapy within 3 months of screening Significant medical condition, laboratory abnormality, or psychiatric condition that would prevent the patient from participating in the study. Any condition or concomitant medication that would confound the ability to interpret data from the study.

Sites / Locations

  • Rocky Mountain Kidney Care - Lone TreeRecruiting
  • Accel ResearchRecruiting
  • Total Research GroupRecruiting
  • Florida Pulmonary Research InstituteRecruiting
  • Nephrology and Hypertension Specialists, PC-DaltonRecruiting
  • Boise Kidney & Hypertension PLLCRecruiting
  • Aventiv Research IncRecruiting
  • Clinical Advancement Center, PLLCRecruiting
  • Endeavor Clinical TrialsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Phase 1b Dose Escalation

Placebo

Arm Description

Single ascending dose of DISC-0974

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events
Incidence of clinically abnormal vital signs
Incidence of abnormal laboratory test results
Incidence of clinically abnormal physical exam
Incidence of clinically abnormal electrocardiograms

Secondary Outcome Measures

Change from baseline in concentration of iron laboratory parameter
Change from baseline in concentration of hematologic laboratory parameters
Cmax-Maximum drug concentration measured in plasma
Tmax-Time of maximum drug concentration
AUC-Area under the drug concentration time curve
T½ - Elimination half life of the drug
CL/F-Apparent drug clearance
Vd/F-Apparent volume of distribution of the drug

Full Information

First Posted
February 16, 2023
Last Updated
October 12, 2023
Sponsor
Disc Medicine, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05745883
Brief Title
Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants With CKD and Anemia
Official Title
A Phase 1b Multicenter, Randomized, Double-Blind, Placebo-Controlled Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DISC-0974 in Participants With Non-Dialysis Dependent Chronic Kidney Disease and Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Disc Medicine, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This Phase 1b study of DISC-0974 will assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of DISC-0974 in adult participants with Non-Dialysis Dependent Chronic Kidney Disease and Anemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Anemia of Chronic Kidney Disease
Keywords
Chronic Kidney Disease, Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1b Dose Escalation
Arm Type
Experimental
Arm Description
Single ascending dose of DISC-0974
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DISC-0974
Intervention Description
DISC-0974 is administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is administered subcutaneously
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events
Time Frame
up to 8 weeks
Title
Incidence of clinically abnormal vital signs
Time Frame
up to 8 weeks
Title
Incidence of abnormal laboratory test results
Time Frame
up to 8 weeks
Title
Incidence of clinically abnormal physical exam
Time Frame
up to 8 weeks
Title
Incidence of clinically abnormal electrocardiograms
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in concentration of iron laboratory parameter
Time Frame
up to 8 weeks
Title
Change from baseline in concentration of hematologic laboratory parameters
Time Frame
up to 8 weeks
Title
Cmax-Maximum drug concentration measured in plasma
Time Frame
up to 8 weeks
Title
Tmax-Time of maximum drug concentration
Time Frame
up to 8 weeks
Title
AUC-Area under the drug concentration time curve
Time Frame
up to 8 weeks
Title
T½ - Elimination half life of the drug
Time Frame
up to 8 weeks
Title
CL/F-Apparent drug clearance
Time Frame
up to 8 weeks
Title
Vd/F-Apparent volume of distribution of the drug
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Aged ≥18 years of age at the time of signing informed consent. Non-dialysis dependent chronic kidney disease, stages 2-5, defined as eGFR <90 mL/min/1.73m2 using the 2021 CKD-EPI formula Women: Hemoglobin <10.5 g/dL; Men: Hemoglobin <11.0 g/dL Serum ferritin ≥100 μg/L at Screening Transferrin saturation ≤35% Body mass index (BMI) of 18.5 to 45.0 kg/m2, inclusive, at screening Aspartate aminotransferase (AST) and alanine transaminase (ALT) <2× upper limit of normal (ULN) at Screening. Total and direct bilirubin <ULN at Screening. Exclusion Criteria: Treatment within 2 days prior to screening with oral iron or iron-containing supplements. Participants may be considered for the study if they undergo a 2-day washout period prior to signing the informed consent form (ICF) and screening for oral iron or iron-containing supplements. Treatment within 30 days prior to screening with one of the following anemia treatments: erythropoietin-stimulating agent or IV iron. Participants may be considered for the study if they undergo a 30-day washout period prior to signing the informed consent form (ICF) and screening for erythropoietin-stimulating agent or IV iron. Acute dialysis or acute kidney injury within 12 weeks prior to screening or expected need to start dialysis within 12 weeks of screening. Hospitalization for a cardiovascular, renal, or cardiorenal condition within 30 days prior to screening. Positive direct antiglobulin test with reactive eluate at screening or active hemolytic anemia. History of hereditary hemochromatosis. History of hemoglobinopathy or intrinsic red blood cell defect associated with anemia. History of total splenectomy. Hematopoietic stem cell or solid organ transplant within the past 10 years. Medical history of anemia from Vitamin B12 or folate deficiency, infection, or bleeding in the 3 months prior to screening Blood transfusion within 3 months of screening Stroke, myocardial infarction, deep venous thrombosis, pulmonary or arterial embolism within 6 months prior to Screening If female, pregnant or breastfeeding. Any major surgery within 8 weeks before Screening or incomplete recovery from any previous surgery. History of malignancy within the last 3 years. The following history/concurrent conditions are allowed: basal or squamous cell carcinoma, carcinoma in situ of the cervix, carcinoma in situ of the breast, histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system). A history of completed treatment (medical or surgical) of Stage 1-2 cancers may be permitted with prior Sponsor agreement. Participation in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices within 30 days of Screening A history or known allergic reaction to any investigational product excipients or history of anaphylaxis to any food or drug History of anti-drug antibody formation History of inadequately controlled heart disease (New York Heart Association Classification 3 or 4) and/or have a history of left ventricular ejection fraction <35% Uncontrolled fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement, despite appropriate treatment) Human immunodeficiency virus positive, active Hepatitis B, or active Hepatitis C. Uncontrolled diabetes mellitus or diabetes mellitus requiring initiation of insulin therapy within 3 months of screening Significant medical condition, laboratory abnormality, or psychiatric condition that would prevent the patient from participating in the study. Any condition or concomitant medication that would confound the ability to interpret data from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Disc Medicine Clinical Trials
Phone
(617) 674 9274
Email
clinicaltrials@discmedicine.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Will Savage, MD PhD
Organizational Affiliation
Disc Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Rocky Mountain Kidney Care - Lone Tree
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holly Peasley
Phone
817-235-4469
Email
holly.peasley@usrenalcare.com
First Name & Middle Initial & Last Name & Degree
Geoffrey A Block, MD
Facility Name
Accel Research
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cary Carrion
Email
ccarrion@accelclinical.com
First Name & Middle Initial & Last Name & Degree
Bruce Rankin, MD
Facility Name
Total Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendaling Bruce
Email
Kendaling@TotalResearchGroup.com
First Name & Middle Initial & Last Name & Degree
Juan Fernandez, MD
Facility Name
Florida Pulmonary Research Institute
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivette Moreno
Email
imoreno@flourishresearch.com
First Name & Middle Initial & Last Name & Degree
Jorge Monroy, MD
Facility Name
Nephrology and Hypertension Specialists, PC-Dalton
City
Dalton
State/Province
Georgia
ZIP/Postal Code
30720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela McCamy
Phone
706-802-2493
Email
amccamy@usrenalcare.com
First Name & Middle Initial & Last Name & Degree
Frank Newby, MD, Ph.D
Facility Name
Boise Kidney & Hypertension PLLC
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Steinmetz
Email
samantha.hickey@frenovarenalresearch.com
First Name & Middle Initial & Last Name & Degree
Arnold Silva, MD, PhD
Facility Name
Aventiv Research Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Deutchman
Email
Adam.Deutchman@centricityresearch.com
First Name & Middle Initial & Last Name & Degree
Samir Arora, MD
Facility Name
Clinical Advancement Center, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Kotara
Email
dkotara@raparesearch.com
First Name & Middle Initial & Last Name & Degree
Pablo E Pergola, MD, PhD
Facility Name
Endeavor Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ericka Ross
Email
Eross@ergclinical.com
First Name & Middle Initial & Last Name & Degree
Grant Garbo, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants With CKD and Anemia

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