Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1) (AEGIS-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01340872
Recruitment Status : Completed
First Posted : April 25, 2011
Last Update Posted : August 31, 2016
Information provided by (Responsible Party):
Shield Therapeutics

Brief Summary:
The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation, is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with non-active ulcerative colitis (UC).

Condition or disease Intervention/treatment Phase
Iron Deficiency Anaemia Inflammatory Bowel Disease Ulcerative Colitis Drug: ST10-021 Drug: Placebo Comparator Phase 3

Detailed Description:

As no curative treatment is currently available for ulcerative colitis (UC), treatment options are restricted to controlling symptoms, maintaining remission and preventing relapse. As such, treatment of iron deficiency anaemia (IDA), a key symptom of the disease, is integral to the medical management of UC. Iron deficiency anaemia in UC is a chronically debilitating disorder which has a significant impact on the quality of life of affected subjects. Characteristic symptoms of IDA include chronic fatigue, headache, and subtle impairment of cognitive function. Up to one third of subjects with UC suffer from recurrent anaemia, with hospitalization required in severe cases. First line standard therapy for mild to moderate IDA in UC is typically oral ferrous products (OFP), however this is often not successful. Many subjects are intolerant and suffer from continuously occurring side effects, occasional exacerbation of inflammatory lesions and failure to correct iron deficiency. Common adverse effects of OFP include nausea, epigastric discomfort and constipation, all of which are dose-related and appear especially evident in subjects with UC.

As compared to oral ferrous iron, oral ferric iron can be administered with improved tolerability and the total dose exposure of unabsorbed iron within the gastrointestinal tract is significantly reduced. In addition, the iron is retained in its chelated form if not absorbed and this may reduce the risk of irritation within the gastrointestinal tract. Clinical studies conducted to date provide preliminary evidence for the therapeutic potential of ST10-021 in patients with IDA in Inflammatory Bowel Disease, including UC.

The purpose of this study is to determine whether ST10-021 is safe and effective in the treatment of IDA in subjects with non-active UC. In an effort to target an underserved population, the study will include only those subjects who have failed OFP in the past, or where OFP cannot be used.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study With Oral ST10-021 for the Treatment of Iron Deficiency Anaemia in Subjects With Quiescent Ulcerative Colitis Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEGIS 1)
Study Start Date : August 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ST10-021
oral ferric iron compound
Drug: ST10-021
30 mg capsules to be taken orally twice a day for 12 weeks
Other Names:
  • Ferric Trimaltol
  • Ferric maltol
  • Feraccru
Placebo Comparator: Sugar pill Drug: Placebo Comparator
Matching sugar pill to be taken orally twice a day for 12 weeks

Primary Outcome Measures :
  1. Change in Hb concentration from baseline to Week 12 [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Number of subjects that achieve an increase in Hb concentration by ≥1 g/dl over the trial period [ Time Frame: up to Week 12 ]
  2. Number of subjects that achieve an increase in Hb concentration by ≥2 g/dl over the trial period [ Time Frame: up to Week 12 ]
  3. Number of subjects that achieve Hb concentration within normal range over the trial period [ Time Frame: up to Week 12 ]
  4. Change in Hb concentration from baseline to Week 8 [ Time Frame: Week 8 ]
  5. Change in Hb concentration from baseline to Week 4 (early response) [ Time Frame: Week 4 ]
  6. Change in quality of life (QOL) based upon changes of the SF-36 QOL questionnaire from baseline to Week 12 [ Time Frame: Week 12 ]
  7. Treatment emergent Adverse Events, Serious Adverse Events, and clinically relevant laboratory abnormalities [ Time Frame: up to Week 66 ]
  8. Change from baseline to Week 12 of SCCAI [ Time Frame: Week 12 ]
    The Simple Clinical Colitis Activity Index (SCCAI) is a measure of ulcerative colitis (UC) disease activity

  9. Change from baseline to Week 12 in vital signs: blood pressure, heart rate and body weight [ Time Frame: Week 12 ]
  10. Adverse events leading to premature discontinuation of study drug [ Time Frame: up to Week 64 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Competency to understand and sign the IEC/IRB approved informed consent form prior to any study mandated procedure, and willing/able to comply with study requirements
  • Age ≥ 18 years
  • Current diagnosis of quiescent UC as defined by SCCAI score of < 4
  • Current diagnosis of IDA as defined by Hb ≥ 9.5 g/dl and <12.0 g/dl for women and ≥ 9.5 g/dl and <13.0 g/dl for men; ferritin < 30 µg/l
  • Prior OFP failure as defined per protocol
  • If receiving protocol-allowed immunosuppressant must be on stable dose
  • Females of childbearing potential must agree to use a reliable method of contraception

Exclusion Criteria:

  • Anaemia due to any cause other than iron deficiency
  • Intramuscular or intravenous injection or administration of depot iron preparation, blood infusions, or erythropoietin within 3 months
  • Oral iron supplementation use within 1 month
  • Use of immunosuppressant with known effect of anaemia induction within 1 month
  • Vitamin B12 or Folic Acid injection/infusion within 4 weeks
  • Untreated Vitamin B-12 or Folic Acid deficiency
  • Known hypersensitivity or allergy to ST10-021 or components of the study medication, or contraindication for treatment with iron preparations
  • Other chronic or acute inflammatory or infectious diseases
  • Creatinine > 2.0 mg/dl
  • AST or ALT levels ≥ 5 times the upper limit of normal
  • Cardiovascular, liver, renal, hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that may adversely affect the safety of the subject and/or efficacy of the study drug or severely limit the lifespan of the subject
  • History of malignancy within the past 5 years (except in situ removal of basal cell carcinoma)
  • Significant neurologic or psychiatric symptoms resulting in disorientation, memory impairment, or inability to report accurately that might interfere with treatment compliance, study conduct or interpretation of the results
  • Participation in another interventional clinical study within 30 days or during the study
  • Inmates of a psychiatric ward, prison, or other state institution
  • Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
  • Scheduled or expected hospitalization and/or surgery during the course of the study
  • Females who are pregnant or lactating

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 identifier (NCT number): NCT01340872

Sponsors and Collaborators
Shield Therapeutics
Study Director: Ian Foley, Ph.D Shield Therapeutics

Additional Information:
Publications of Results:
Responsible Party: Shield Therapeutics Identifier: NCT01340872     History of Changes
Other Study ID Numbers: ST10-01-301
2010-023588-16 ( EudraCT Number )
First Posted: April 25, 2011    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shield Therapeutics:
iron deficiency
inflammatory bowel disease
ulcerative colitis

Additional relevant MeSH terms:
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Trace Elements
Growth Substances
Physiological Effects of Drugs