Back to resultsPhase Ib Study to Evaluate PRS-080 in Anemic Chronic Kidney Disease Patients
Primary Purpose
Anemia of Chronic Kidney Disease
Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
PRS-080#022-DP
PRS-080-Placebo#001
Sponsored by
About this trial
This is an interventional treatment trial for Anemia of Chronic Kidney Disease focused on measuring Hepcidin, hemoglobin, iron, anemia of chronic disease
Eligibility Criteria
Inclusion Criteria:
- Patients with stage 5 chronic kidney disease having been on hemodialysis for at least 90 days
- Patients being on stable erythropoiesis-stimulating agent (ESA) dose
- Hemoglobin (Hb) 9 - 11 g/dL
- Ferritin ≥ 300 ng/mL.
- Transferrin saturation (TSAT) ≤ 30%
- Hepcidin 5 - 50 nmol/L
Exclusion Criteria:
- Anemia due to causes other than chronic kidney disease, including hemoglobinopathies, hemolytic anemias, myelodysplasia or malignancy
- Blood transfusion within 2 months before administration of study medication.
- Iron treatment from 1 week before study medication administration until 1 week after study medication administration.
- Previous enrollment in this study
- Current or previous (within 60 days before study medication administration) treatment with another investigational drug and/or medical device or participation in another clinical study.
- Pregnancy or breast-feeding women of child bearing age.
- Known allergy to any component of the PRS-080#022-DP formulation
- Positive for hepatitis B surface antigen, anti-hepatitis C virus antibody, or human immunodeficiency virus
- Planned surgery during the study period
- Unwilling or unable to comply with the protocol, in the judgment of the investigator
- Unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty/stents, apoplexy or coronary artery bypass grafting <3 months prior screening.
- Congestive heart failure: New York Heart Association Class III or IV.
Sites / Locations
- St. Joseph Krankenhaus
- Technical University, Medical Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PRS-080#022-DP
PRS-080-Placebo#001
Arm Description
Hepcidin antagonist, single administration, ascending doses
Comparator treatment, single administration
Outcomes
Primary Outcome Measures
Number of patients with adverse events
Composite measure including signs and symptoms, changes from baseline heart rate and blood pressure, ECG, body temperature, respiratory rate clinical chemistry and hematology
Secondary Outcome Measures
Pharmacokinetics of PRS-080#022
Area under the plasma concentration versus time curve (AUC) of PRS-080 in plasma
Effects of PRS-080#022 on serum iron
Changes in total serum iron concentration compared to baseline
Effects of PRS-080#022 on ferritin
Changes in serum ferritin concentration compared to baseline
Effects of PRS-080#022 on transferrin saturation
Changes in serum transferrin saturation compared to baseline
Effect of PRS-080#022 on hepcidin concentrations in plasma
Changes in hepcidin concentration compared to baseline
Number of patients developing anti-drug antibodies
Number of patients with antibodies against PRS-080#022 at day 28 compared to baseline.
Full Information
NCT ID
NCT02754167
First Posted
April 14, 2016
Last Updated
October 19, 2017
Sponsor
Pieris Pharmaceuticals GmbH
Collaborators
FGK Clinical Research GmbH
1. Study Identification
Unique Protocol Identification Number
NCT02754167
Brief Title
Phase Ib Study to Evaluate PRS-080 in Anemic Chronic Kidney Disease Patients
Official Title
Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Hepcidin Antagonist PRS-080#022-DP in Anemic Chronic Kidney Disease Patients Undergoing Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 6, 2016 (Actual)
Primary Completion Date
February 6, 2017 (Actual)
Study Completion Date
December 31, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pieris Pharmaceuticals GmbH
Collaborators
FGK Clinical Research GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Anticalins® are engineered human proteins that are able to bind specific target molecules. The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin and is intended for the treatment of anemia of chronic disease. This Phase Ib study shall investigate the safety, pharmacokinetics and pharmacodynamics of a single administration of PRS-080#022-DP in anemic stage 5 chronic kidney disease patients undergoing hemodialysis.
Detailed Description
This is a multi-center, randomized, double-blind, placebo-controlled, single ascending dose phase Ib study in anemic stage 5 chronic kidney disease patients requiring hemodialysis. Eligible subjects will undergo screening assessments and PRS-080#22-DP will be administered by intravenous infusion. The study will consist of 3 dose cohorts of 2 mg/kg, 4 mg/kg, and 8 mg/kg body weight with 8 subjects in each cohort. Using a standard 6+2 design, 6 subjects in each cohort will be randomized to PRS-080#022-DP and 2 subjects in each cohort will be randomized to placebo. The decision to escalate the dose will be based on an interim analysis of clinical safety and safety laboratory data. Safety and tolerability, pharmacokinetics, pharmacodynamics as well as potential immunogenicity will be investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia of Chronic Kidney Disease
Keywords
Hepcidin, hemoglobin, iron, anemia of chronic disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRS-080#022-DP
Arm Type
Experimental
Arm Description
Hepcidin antagonist, single administration, ascending doses
Arm Title
PRS-080-Placebo#001
Arm Type
Placebo Comparator
Arm Description
Comparator treatment, single administration
Intervention Type
Biological
Intervention Name(s)
PRS-080#022-DP
Other Intervention Name(s)
PRS-080
Intervention Description
Hepcidin antagonism to mobilize iron and to treat anemia
Intervention Type
Biological
Intervention Name(s)
PRS-080-Placebo#001
Other Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Number of patients with adverse events
Description
Composite measure including signs and symptoms, changes from baseline heart rate and blood pressure, ECG, body temperature, respiratory rate clinical chemistry and hematology
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Pharmacokinetics of PRS-080#022
Description
Area under the plasma concentration versus time curve (AUC) of PRS-080 in plasma
Time Frame
28 days
Title
Effects of PRS-080#022 on serum iron
Description
Changes in total serum iron concentration compared to baseline
Time Frame
28 days
Title
Effects of PRS-080#022 on ferritin
Description
Changes in serum ferritin concentration compared to baseline
Time Frame
28 days
Title
Effects of PRS-080#022 on transferrin saturation
Description
Changes in serum transferrin saturation compared to baseline
Time Frame
28 days
Title
Effect of PRS-080#022 on hepcidin concentrations in plasma
Description
Changes in hepcidin concentration compared to baseline
Time Frame
28 days
Title
Number of patients developing anti-drug antibodies
Description
Number of patients with antibodies against PRS-080#022 at day 28 compared to baseline.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with stage 5 chronic kidney disease having been on hemodialysis for at least 90 days
Patients being on stable erythropoiesis-stimulating agent (ESA) dose
Hemoglobin (Hb) 9 - 11 g/dL
Ferritin ≥ 300 ng/mL.
Transferrin saturation (TSAT) ≤ 30%
Hepcidin 5 - 50 nmol/L
Exclusion Criteria:
Anemia due to causes other than chronic kidney disease, including hemoglobinopathies, hemolytic anemias, myelodysplasia or malignancy
Blood transfusion within 2 months before administration of study medication.
Iron treatment from 1 week before study medication administration until 1 week after study medication administration.
Previous enrollment in this study
Current or previous (within 60 days before study medication administration) treatment with another investigational drug and/or medical device or participation in another clinical study.
Pregnancy or breast-feeding women of child bearing age.
Known allergy to any component of the PRS-080#022-DP formulation
Positive for hepatitis B surface antigen, anti-hepatitis C virus antibody, or human immunodeficiency virus
Planned surgery during the study period
Unwilling or unable to comply with the protocol, in the judgment of the investigator
Unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty/stents, apoplexy or coronary artery bypass grafting <3 months prior screening.
Congestive heart failure: New York Heart Association Class III or IV.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lutz Renders, Prof. MD
Organizational Affiliation
Technical University, Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph Krankenhaus
City
Berlin
Country
Germany
Facility Name
Technical University, Medical Department
City
Munich
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://pieris.com
Description
Pieris Pharmaceuticals
Learn more about this trial
Phase Ib Study to Evaluate PRS-080 in Anemic Chronic Kidney Disease Patients
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