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Anemia of Chronic Kidney DiseasePhase 1/2NCT03325621

Phase 2a Study to Evaluate PRS-080 in Anemic Chronic Kidney Disease Patients

A Phase 1/2 study testing PRS-080#022-DP in people with Anemia of Chronic Kidney Disease, run by Pieris Pharmaceuticals GmbH at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Anticalin® proteins 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia of Chronic Kidney Disease
What is being tested?
PRS-080#022-DP
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
11 participants
Where
6 sitesin 2 countries
Study dates
30 Sep 2017to 30 Jun 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with stage 5 CKD having been on hemodialysis for at least 90 days;
  • Male and post-menopausal (no menses for at least 12 months without an alternative medical cause) female patients with an age of ≥18 years and with a maximum body weight of 85 kg;
  • Patients being on stable erythropoiesis stimulating agent dose for 4 weeks prior to Screening;
  • Patients being on stable oral or intravenous iron doses for 4 weeks prior to Screening;
  • Mean of 3 Hb values during the screening period, each obtained at least 7 days apart must be ≤10.5 g/dL, with a difference of ≤1.0 g/dL between the lowest and highest value;
  • Serum ferritin concentration ≥300 ng/mL;
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  • Transferrin saturation ≤30%;
  • Plasma hepcidin concentration at least 5 nmol/L;
  • Screening serum folate and vitamin B12 ≥lower limit of normal Hepcidin 5 - 50 nmol/L;
  • Male patients with a female partner of childbearing potential agree to use a medically acceptable method of contraception (e.g., condoms, sexual abstinence, vasectomy), not including the rhythm method for 30 days after administration of the study medication; and
  • The patient is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF). Patient agrees to comply with the protocol-mandated procedures and visits.

Who cannot join

  • 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;
  • Previous enrollment in this study;
  • Patients treated with PRS-080#022-DP in a previous clinical study;
  • Current or previous (within 60 days or 5 half-lives before study medication administration) treatment with another investigational drug and/or medical device or participation in another clinical study;
  • Employees of the sponsor or patients who are employees or relatives of the investigator;
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  • Known allergy to any component of the PRS-080#022-DP formulation;
  • Positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus antibody (anti-hepatitis C virus Ab), or human immunodeficiency virus (HIV), serology test results not older than 3 months are accepted;
  • Planned surgery during the study period;
  • Known or suspected active infection;
  • Active or chronic gastrointestinal bleeding, or known coagulation disorder;
  • Unwilling or unable to comply with the protocol, in the judgment of the investigator;
  • Unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty/stents, apoplexy (sudden circulatory disturbances of an organ or specific region of the body) or coronary artery bypass grafting <3 months prior to Screening;
  • Congestive heart failure: New York Heart Association Class III or IV;
  • Peripheral arterial disease with necrosis, stage IV (Fontaine) or grade III (category 5 and 6, Rutherford); and
  • Any medical condition that in the judgment of the investigator might interfere with study participation or jeopardize patient's safety during the study (e.g., active infection).

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Czechia4 sites

  • University Hospital Brno

    Brno, 625 00

  • HDS - Klaudian's Hospital

    Mladá Boleslav, 293 50

  • Institute of Clinical and Experimental Medicine (ICEM)

    Prague, 140 21

  • VFN Strahov

    Prague, 169 00

Other trials in Czechia

Germany2 sites

  • MZV DaVita

    Düsseldorf, 40210

  • Technical University Munich

    Munich, 81675

Other trials in Germany

About this study

Official title: Phase 2a Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Repeated Administrations Over 4 Weeks of the Hepcidin Antagonist PRS-080#022-DP in Anemic Chronic Kidney Disease Patients Undergoing Hemodialysis

Anticalin® proteins 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 pilot Phase 2a study shall investigate the safety, pharmacokinetics and pharmacodynamics of repeated administrations of PRS-080#022-DP in anemic stage 5 chronic kidney disease (CKD) patients undergoing hemodialysis.

Read the detailed description

This is a multi-center, randomized, double-blind, placebo-controlled, multiple ascending dose, pilot Phase 2a study in anemic stage 5 chronic kidney disease patients requiring hemodialysis. Eligible patients will undergo screening assessments and PRS-080#22-DP will be administered by intravenous infusion. The study will consist of 2 dose cohorts of 4 mg/kg and 8 mg/kg body weight with 6 patients in each cohort. Using a standard 4+2 design, 4 patients in each cohort will be randomized to PRS-080#022-DP and 2 patients in each cohort will be randomized to placebo. The decision to escalate the dose will be based on an interim analysis of clinical and laboratory safety as well on a comparison with pharmacokinetic data. Safety and tolerability, pharmacokinetics, pharmacodynamics as well as potential immunogenicity will be investigated.

Being tested
PRS-080#022-DP, PRS-080-Placebo#001
Keywords
Hepcidin, Hemoglobin, Iron, Anemia of chronic disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRS-080#022-DPBiological

    Also called PRS-080

    Biological/Vaccine: PRS-080#022-DP Hepcidin antagonism to mobilize iron and to treat anemia

  • PRS-080-Placebo#001Biological

    Also called Placebo

    Placebo Comparator

Study groups in NCT03325621
Study groupRoleWhat they receive
PRS-080#022-DPActive comparatorExperimental: PRS-080#022-DP Hepcidin antagonist, repeated administrations, ascending doses
Receives: Biological: PRS-080#022-DP
PRS-080-Placebo#001Placebo comparatorExperimental: PRS-080-Placebo#001 Comparator treatment, repeated administrations
Receives: Biological: PRS-080-Placebo#001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 112 days

Secondary outcomes (10)

  1. Cmax

    Measuring the maximum concentration of PRS-080#022 in the blood

    Measured: 112 days

  2. Effects of PRS-080#022 on serum iron

    Changes in total serum iron concentration compared to baseline

    Measured: 56 days

  3. Effects of PRS-080#022 on ferritin

    Changes in serum ferritin concentration compared to baseline

    Measured: 56 days

  4. Effects of PRS-080#022 on transferrin saturation

    Changes in serum transferrin saturation compared to baseline

    Measured: 56 days

  5. Effect of PRS-080#022 on hepcidin concentrations in plasma

    Changes in hepcidin concentration compared to baseline

    Measured: 56 days

  6. Number of patients developing anti-drug antibodies

    Number of patients with antibodies against PRS-080#022 at day 28 compared to baseline

    Measured: 112 days

  7. Effects on red blood cell Hb concentration

    Changes in Hb concentration compared to baseline

    Measured: 56 days

  8. ctrough

    Measuring the concentration of PRS-080#022 before the drug application

    Measured: 112 days

  9. tmax

    Evaluation of the time for PRS-080#022 to reach maximum concentration

    Measured: 112 days

  10. Elimination of PRS-080#022

    Evaluation of Terminal rate constant and terminal half-life (t½ ) after the very last administration of PRS-080 in plasma

    Measured: 112 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2017
  2. Study start30 Sep 2017
  3. Primary completion30 Mar 2019
  4. Study completion30 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, double-blind, placebo-controlled, two dose groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03325621
Sponsor's protocol ID
PCS_03_16
Status last verified
Nov 2018
First submitted
19 Oct 2017
Last updated
21 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PRS-080#022-DP in people with Anemia of Chronic Kidney Disease, run by Pieris Pharmaceuticals GmbH at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Czechia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with adverse events (time frame: 112 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03325621.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.

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