Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered as Single Bolus Injections in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)

NCT01469078 | Completed Phase 1 DMC

• 1 other identifier: P-Monofer-PK-CKD-05
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 100 mg, 200 mg or 500 mg in subjects with Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease; CKD stage 5; Iron deficiency

Outcome Measures

Primary Outcomes (1)

• Determination of changes in Iron pharmacokinetic parameters from plasma/serum concentration profile

  The follwoing parameter will be determined: AUC0-t, AUC, Cmax, Tmax, Ke, and T1/2

  From exposure to 7 days post-exposure

Secondary Outcomes (2)

• Changes in pharmacodynamic parametres

  From 0 hours to 4, 8, 24, 48, 72 hours post-exposure and end of study visit

• Safety evaluation

  From screening to 7 days post-exposure

Study Arms (3)

100 mg Monofer®

ACTIVE COMPARATOR

Drug: Monofer®

200 mg Monofer®

ACTIVE COMPARATOR

Drug: Monofer®

500 mg Monofer®

ACTIVE COMPARATOR

Drug: Monofer®

Interventions

Monofer® DRUG

Single Bolus Injections

100 mg Monofer®; 200 mg Monofer®; 500 mg Monofer®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, aged more than 18 years.
• Weight above 50 kg.
• Serum ferritin ≤ 800 ng/mL.
• Transferrin Saturation ≤ 35%.
• Life expectancy beyond 12 months by Principal Investigator's judgement.
• Hb concentrations ≥10.0 g/dL and ≤12.5 g/dL both at Screening Visit 1a and at Screening Visit 1b (Screening Visit 1a and Visit 1b must be separated by at least 1 week).
• Willingness and ability to participate after informed consent (including HIPAA, if applicable).

You may not qualify if:

• Anemia caused primarily by other factors than renal related anemia.
• Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis).
• Difference of Hb ≥ 1.0 g/dL between Screening Visits 1a and 1b.
• Known hypersensitivity to any excipients in the investigational drug products.
• Subjects with a history of multiple allergies.
• Decompensated liver cirrhosis and history of hepatitis B or C \[Alanine Aminotransferase (ALT) \> 3 times upper limit of normal\].
• Acute or chronic infections (assessed by clinical investigator judgment), supported by White Blood Cells (WBC) and C-Reactive Protein (CRP).
• Rheumatoid arthritis with symptoms or signs of active joint inflammation.
• Pregnant or nursing women.
• Women of child bearing potential who are not using safe contraceptive methods (e.g. intrauterine device, oral contraceptives or surgically sterilized) or who are planning to become pregnant within the study period.
• Blood transfusion within the previous 12 weeks.
• Planned elective surgery during the study where significant blood loss is expected.
• Participation in any other clinical trial within 3 months prior to screening.
• Untreated Vitamin B12 or folate deficiency.
• Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. Examples include Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.

Sponsors & Collaborators

• Pharmacosmos A/S: lead
• ClinSmart: collaborator

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Iron Deficiencies

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: November 10, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 8, 2012

Record last verified: 2012-11