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Trial record 58 of 380 for:    FERRIC CATION

KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial) (COMPASS)

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ClinicalTrials.gov Identifier: NCT03236246
Recruitment Status : Completed
First Posted : August 1, 2017
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Keryx Biopharmaceuticals

Brief Summary:
The objectives of this study are to assess the long-term efficacy and safety of different dose regimens of KRX-0502 in the treatment of iron deficiency anemia (IDA) in adult subjects with non-dialysis dependent chronic kidney disease (CKD).

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Iron Deficiency Anemia Drug: KRX-0502 Phase 4

Detailed Description:
This is a 48-week, randomized, open-label, multicenter clinical study comprised of 2 periods: a 24-week Dose Titration Period, followed by a 24-week Dose Maintenance Period. The study will consist of 12 scheduled clinic visits over a period of 48 weeks and additional visits as needed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of KRX-0502 (Ferric Citrate) Dose Regimens in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and Iron-Deficiency Anemia
Actual Study Start Date : July 26, 2017
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : September 27, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
KRX-0502 1 tablet thrice daily (TID) with meals
Drug: KRX-0502
Oral ferric citrate with meals
Other Name: ferric citrate

Experimental: Group 2
KRX-0502 2 tablets twice daily (BID) with the largest 2 daily meals
Drug: KRX-0502
Oral ferric citrate with meals
Other Name: ferric citrate




Primary Outcome Measures :
  1. Change from Baseline in Hgb [ Time Frame: 24 week ]
    Change in Hgb from Baseline


Secondary Outcome Measures :
  1. Change from Baseline in Hgb [ Time Frame: 48 week ]
    Change in Hgb from Baseline

  2. Change from Baseline in TSAT [ Time Frame: 24 week ]
    Change in TSAT from Baseline

  3. Change from Baseline in TSAT [ Time Frame: 48 week ]
    Change in TSAT from Baseline

  4. Change from Baseline in Ferritin [ Time Frame: 24 week ]
    Change in Ferritin from Baseline

  5. Change from Baseline in Ferritin [ Time Frame: 48 week ]
    Change in Ferritin from Baseline

  6. Number of Participants with SAEs and AEs [ Time Frame: 48 week ]
    Number of Participants with Adverse Events and Serious Adverse Events that are related to treatment



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

Inclusion Criteria:

  • Estimated glomerular filtration rate ≥20 mL/min and <60 mL/min
  • Hgb ≥8.5 g/dL and ≤11.5 g/dL
  • Serum ferritin ≤500 ng/mL and transferrin saturation (TSAT) ≤25%
  • Serum intact parathyroid hormone ≤600 pg/mL

Exclusion Criteria:

  • Serum phosphate <3.0 mg/dL
  • Intravenous (IV) iron administered within 4 weeks prior to Screening
  • Erythropoiesis-stimulating agents (ESA) administered within 4 weeks prior to Screening
  • Blood transfusion within 4 weeks prior to Screening

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): NCT03236246


  Show 28 Study Locations
Sponsors and Collaborators
Keryx Biopharmaceuticals
Investigators
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Study Director: Medical Director Keryx Biopharmaceuticals

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Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT03236246     History of Changes
Other Study ID Numbers: KRX-0502-402
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
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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Ferric Compounds
Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Hematinics