A Study to Evaluate the Soluble Guanylate Cyclase (sGC) Stimulator IW-1973 in Diabetic Nephropathy / Diabetic Kidney Disease as Measured by Albuminuria

August 18, 2022 updated by: Akebia Therapeutics

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of IW-1973 in Patients With Type 2 Diabetes With Albuminuria Treated With Renin-Angiotensin System Inhibitors

To evaluate the safety and efficacy of IW-1973 in patients with type 2 diabetes mellitus with albuminuria who are on a stable regimen of renin-angiotensin system inhibitors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Chula Vista, California, United States, 91910
        • California Institute of Renal Research
      • Fullerton, California, United States, 92835
        • St. Joseph Heritage Healthcare (St. Jude Hospital DBA)
      • La Mesa, California, United States, 91942
        • California Institute of Renal Research
      • Lomita, California, United States, 90717
        • Torrance Clinical Research Institute, Inc.
      • Los Angeles, California, United States, 90022
        • Academic Medical Research Institute
      • Los Angeles, California, United States, 90017
        • American Institute of Research
      • Northridge, California, United States, 91324
        • California Medical Research Associates, Inc. (CMRA)
      • Riverside, California, United States, 92503
        • Riverside Nephrology Physicians, Inc.
      • San Dimas, California, United States, 91773
        • California Kidney Specialists
      • San Dimas, California, United States, 91773
        • North American Research Institute
      • Santa Monica, California, United States, 90025
        • UCLA
      • Torrance, California, United States, 90502
        • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
    • Colorado
      • Denver, Colorado, United States, 80209
        • Creekside Endocrine Associates
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • The George Washington University Medical Faculty Associates
    • Florida
      • Hialeah, Florida, United States, 33012
        • AGA Clinical Trials
      • Miami, Florida, United States, 33144
        • Elite Clinical Research
      • Miami, Florida, United States, 33015
        • Leon Medical Research Corp.
      • Miami, Florida, United States, 33155
        • DL Research Solutions
      • Miami, Florida, United States, 33165
        • Premier Research Associates, Inc.
      • Miami Lakes, Florida, United States, 33016
        • Sweet Hope Research Speciality, Inc.
      • Palmetto Bay, Florida, United States, 33157
        • IMIC, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Center for Clinical Research Nephrology
      • Columbus, Georgia, United States, 31904
        • Columbus Regional Research Institute
      • Lawrenceville, Georgia, United States, 30046
        • Gwinnett Biomedical Research
      • Macon, Georgia, United States, 31210
        • East Coast Institute for Clinical Research
      • Macon, Georgia, United States, 31210
        • East Coast Institute for Research
    • Idaho
      • Nampa, Idaho, United States, 83686
        • Saltzer Medical Group
    • Illinois
      • Chicago, Illinois, United States, 60643
        • Research by Design, LLC
    • Indiana
      • Franklin, Indiana, United States, 46131
        • American Health Network of Indiana
    • Kansas
      • Manhattan, Kansas, United States, 66502
        • My Kidney Center
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Kentucky Diabetes Endocrinology Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center
    • Michigan
      • Flint, Michigan, United States, 48504
        • Aa Mrc, Llc
    • Missouri
      • Saint Louis, Missouri, United States, 63136
        • St. Louis Heart & Vascular, P.C.
    • New Jersey
      • Linden, New Jersey, United States, 07036
        • NJ Heart, P.A.
    • New York
      • Albany, New York, United States, 12206
        • Albany Medical College, Division of Community Endocrinology
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Physicians East Endocrinology
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Mountain View Clinical Research
      • Orangeburg, South Carolina, United States, 29118
        • South Carolina Nephrology & Hypertension Center
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • University of Tennessee Health Science Center at Memphis University Hospital
    • Texas
      • Beaumont, Texas, United States, 77702
        • Pioneer Research Solutions
      • El Paso, Texas, United States, 79935
        • Academy of Diabetes, Thyroid and Endocrine, P.A.
      • Fort Worth, Texas, United States, 76116
        • The Medical Group Of Texas
      • Fort Worth, Texas, United States, 76164
        • Rockwood Medical Center
      • Houston, Texas, United States, 77099
        • Pioneer Research Solutions, Inc.
      • Houston, Texas, United States, 77079
        • Endocrine Ips, Pllc
      • Lampasas, Texas, United States, 76550
        • Fmc Science, Llc
      • San Antonio, Texas, United States, 78215
        • Clinical Advancement Center PLLC
      • San Antonio, Texas, United States, 78224
        • Briggs Clinical Research
    • Virginia
      • Burke, Virginia, United States, 22015
        • Burke Internal Medicine and Research
      • Manassas, Virginia, United States, 20110
        • Manassas Clinical Research Center
    • Washington
      • Spokane, Washington, United States, 99208
        • Northside Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Patient is an ambulatory male or female from 25 to 75 years old at the Screening Visit.
  • Patient has type 2 diabetes diagnosed by a physician or nurse practitioner ≥6 months before the Screening Visit, has been on ≥1 antihyperglycemic medication for ≥12 weeks preceding the Randomization Visit, and has been on a stable regimen (ie, same drug and same dose) of ≥1 antihyperglycemic medication for ≥28 days preceding the Randomization Visit. (Modification of short-acting insulin throughout the Screening Period will not affect eligibility.)
  • Patient has been on a stable regimen (ie, same drug and dose) of antihypertensive medications, which must include an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB), for ≥28 days preceding the Randomization Visit and is expected to remain on their regimen through the Follow-up Visit.

  • Patient has the following:

    1. Estimated glomerular filtration rate (eGFR) 30 to 75 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (1) at the Screening and Baseline Visits
    2. Urine albumin-to-creatinine ratio (UACR) >200 mg/g at the Screening and Baseline Visits and <5000 mg/g at Screening and Baseline Visits
    3. Serum albumin >3.0 g/dL at the Screening and Baseline Visits
    4. Hemoglobin A1c (HbA1c) ≤11% at the Screening and Baseline Visits
    5. Systolic blood pressure (BP) of 110 to 160 mm Hg at the Screening and Baseline Visits
  • Women of childbearing potential must have a negative pregnancy test prior to randomization and must agree to use protocol-specified contraception from the Screening Visit through 60 days after the final dose of study drug.
  • Male patients must be surgically sterile by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis) or must agree to use protocol-specified contraception from the Screening Visit through 60 days after the final dose of study drug.
  • Other inclusion criteria per protocol.

Key Exclusion Criteria:

  • Patient has a history of secondary hypertension (ie, renal artery stenosis, primary aldosteronism, or pheochromocytoma).
  • Patient has a body mass index (BMI) <20 or >45 kg/m2 at the Screening Visit.
  • Patient has a history of platelet dysfunction, hemophilia, von Willebrand disease, coagulation disorder, other bleeding diathesis, or significant, nontraumatic bleeding episode(s), such as from a gastrointestinal source.
  • Patient has hepatic impairment defined as Child-Pugh A, B, C.
  • Patient has significant comorbidities (eg, malignancy, advanced liver disease, pulmonary hypertension, pulmonary fibrosis, lung disease requiring supplemental oxygen) or other significant conditions that, in the Investigator's opinion, would limit the patient's ability to complete or participate in this clinical study; has been hospitalized for cardiovascular, renal, or metabolic cause in the 3 months before the Screening Visit; or has a life expectancy of less than 1 year.
  • Patient has had prior dialysis, renal transplant, or planned renal transplant.

  • Patient has clinically active, symptomatic, or unstable coronary artery or heart disease within the 3 months before the Screening Visit, defined as 1 of the following:

    1. Hospitalization for myocardial infarction (MI), unstable angina, or heart failure
    2. New-onset angina with positive functional study or coronary angiogram revealing stenosis
    3. Coronary revascularization procedure
  • Patient has a history of clinically significant hypersensitivity or allergies to any of the inactive ingredients contained in the active or placebo drug products.
  • Patient has previously received IW-1973 in a study, or received an investigational drug during the 30 days or 5 half-lives of that investigational drug (whichever is longer) before the Screening Visit, or is planning to receive another investigational drug at any time during the study.
  • Patient is taking specific inhibitors of phosphodiesterase 5 (PDE5), nonspecific inhibitors of PDE5 (including dipyridamole and theophylline), any supplements for the treatment of erectile dysfunction, riociguat, or nitrates or nitric oxide (NO) donors in any form. These medications and supplements are prohibited from 7 days before Randomization through the duration of the study.
  • Patient is taking strong cytochrome P450 3A (CYP3A) inhibitors (eg, ketoconazole, indinavir, nelfinavir, ritonavir, saquinavir, clarithromycin, telithromycin, itraconazole, and nefazodone). These medications are prohibited 14 days before Randomization through the duration of the trial.
  • Other exclusion criteria per protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IW-1973 Low Dose
Administered daily for 12 weeks
Drug: IW-1973
Oral Tablet
Experimental: IW-1973 High Dose
Administered daily for 12 weeks
Drug: IW-1973
Oral Tablet
Placebo Comparator: Placebo
Placebo to match experimental drug administered daily for 12 weeks
Drug: Placebo
Oral Tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Study Drug-Related TEAEs
Time Frame: Day 1 up to Day 115
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as those AEs that started or worsened in severity after the initiation of study drug administration. Causality relationship to study drug was per Investigator assessment.
Day 1 up to Day 115
Percent Change From Baseline in Urine Albumin Creatinine Ratio (UACR) Over Weeks 8 and 12
Time Frame: Baseline; Week 8 to Week 12
Urine samples were collected for the analysis of UACR. UACR (milligrams per gram [mg/g]) was calculated as urine albumin (mg per deciliter [mg/dL]) / urine creatinine (g/dL). Change from Baseline was calculated as the average of the UCAR values at Weeks 8 and 12 minus the Baseline value. Data were analyzed using a mixed-effects model repeated measures (MMRM) analysis with change from Baseline in log-transformed UACR as the response variable, treatment, visit, treatment-by visit interaction, and Baseline estimated glomerular filtration rate stratum as fixed effects, Baseline log-transformed UACR and Baseline mean arterial pressure as covariates, and unstructured as the variance-covariance structure.
Baseline; Week 8 to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akebia Therapeutics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cyclerion Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: John Hanrahan, MD MPH, Cyclerion Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C1973-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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