Clinical Trial Details

NCT ID: NCT02968368
Date Last Changed: October 10, 2017

Overview

Research Study Summary

A Phase 3 clinical study for patients with Renal Insufficiency, Chronic or Iron-Deficiency Anemia

Research Study Title

A Phase 3, Randomized, Placebo Controlled, Prospective, Multicenter Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease

Purpose

To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA in subjects with CKD

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Shield Therapeutics
Duration
12 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  1. Subjects must be competent to understand the information given in the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved information sheet and consent form and must sign and date the informed consent prior to any study mandated procedure.

  2. Subjects must be willing and able to comply with study requirements.

  3. Age ≥ 18 years.

  4. Subjects must have a current diagnosis of CKD with an estimated glomerular filtration rate (eGFR) of < 60 ml/min/1.73m2 and ≥15 ml/min/1.73m2, as calculated using the abbreviated version of the Modified Diet in Renal Disease equation (MDRD) assessed via Screening laboratory results.

  5. Subjects must have iron deficiency anemia defined by the following criteria assessed via Screening laboratory results:

  6. Hb < 11.0 and > 8.0g/dl

  7. AND Ferritin < 250 ng/ml

  8. AND Transferrin saturation (TSAT) < 25%

  9. Subjects using ESA agents must have been on a stable dose for at least 8 weeks prior to randomization (i.e no greater than 20% change in weekly dose).

  10. Female subject of childbearing potential (including perimenopausal females who have had a menstrual period within 1 year prior to screening) must agree to use a reliable method of contraception until study completion and for at least 4 weeks following their final study visit. Reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), complete sexual abstinence, or a vasectomized partner. Oral contraceptive medications are allowed in this study. Female subjects who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or postmenopausal (defined as no menstrual period within 1 year of screening) are also allowed to participate.

Exclusion Criteria:

  1. Subject with anemia due to any cause other than iron deficiency, including, but not limited to:

  2. Untreated or untreatable severe malabsorption syndrome.

  3. Myelosuppression use (permitted if taken at a stable dose for at least 3 months prior to Randomization and are expected to stay stable throughout the study treatment period so long as there is no clinical evidence or suspicion of the myelosuppression contributing to the subject's anemia).

  4. Subject who has received any of the following prior to Randomization:

  5. Intravenous (IV) iron injection within the previous 4 weeks or administration of intramuscular or depot iron preparation within previous 12 weeks.

  6. Oral iron supplementation, taken specifically to treat anemia within the previous 2 weeks (multivitamins containing iron are permitted).

  7. Blood transfusion or donation within the previous 12 weeks.

  8. Subject for whom the initiation of dialysis or renal transplant is considered likely during the study.

  9. Subject who received a renal transplant within 12 months prior to Randomization.

  10. Subject with known hypersensitivity or allergy to the active substance or excipients of ferric maltol capsules.

  11. Subject with contraindication for treatment with iron preparations, e.g. hemochromatosis, chronic hemolytic disease, sideroblastic anemia, thalassemia, or lead intoxication induced anemia.

  12. Impaired liver function as indicated by alanine aminotransferase (ALT) or aspartate transaminase (AST) > 3 times the upper limit of normal as assessed via screening laboratory results.

  13. Subjects with clinically significant vitamin B12 or folic acid deficiency as determined by the Screening laboratory results (rescreen following at least 2 weeks of starting treatment with vitamin B12 or folate replacement is permitted).

  14. Subjects who are pregnant or breast feeding.

  15. Concomitant medical conditions with significant active bleeding likely to initiate or prolong anemia; for example coagulation disorders or recurrent GI bleeding.

  16. Subject with scheduled or expected hospitalization and/or surgery during the course of the study; with the exception of surgery related to fistulae or vascular access.

  17. Participation in any other interventional clinical study within 30 days prior to Screening.

  18. Subject with cardiovascular, liver, renal, hematologic, psychiatric, neurologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that, in the opinion of the Investigator, may adversely affect the safety of the subject and/or efficacy of the study drug or severely limit the lifespan of the subject.

Site Locations (27)

Country State City Zip Facility and Contact
United States Arizona Peoria Research Site
United States Arizona Phoenix Research Site
United States Arizona Prescott Research Site
United States Arizona Tucson Research Site
United States California La Mesa Research Site
United States California Long Beach Research Site
United States California Roseville Research Site
United States California Sacramento Research Site
United States Colorado Denver Research Site
United States Florida Coral Springs Research Site
United States Florida Edgewater Research Site
United States Florida Lauderdale Lakes Research Site
United States Florida Miami Research Site
United States Georgia Macon Research Site
United States Louisiana Shreveport Research Site
United States Michigan Pontiac Research Site
United States Michigan Roseville Research Site
United States Nevada Las Vegas Research Site
United States North Carolina Asheville Research Site
United States North Carolina Charlotte Research Site
United States North Carolina Wilmington Research Site
United States Pennsylvania Bethlehem Research Site
United States Tennessee Knoxville Research Site
United States Tennessee Nashville Research Site
United States Texas El Paso Research Site
United States Texas San Antonio Research Site
United States Virginia Hampton Research Site

Contact

Mark R Sampson, MBChB
+44 7733 304886
E-mail:

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