AnemiaPhase 1NCT00097747
Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers
A Phase 1 study testing peginesatide in people with Anemia and Chronic Kidney Disease, run by Affymax at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and minimum pharmacologically active dose of peginesatide in Healthy Volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia, Chronic Kidney Disease, Chronic Renal Failure
- What is being tested?
- peginesatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2004to Jan 2005
- Phase
- Phase 1
- 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 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Main eligibility criteria:
- Participant is a healthy male, age ≥ 18 years and ≤ 40 years, with body mass index (BMI) ≥ 18 and ≤ 30 kilograms per squared meter (kg/m^2), and weight ≥ 50 and ≤ 95 kilograms (kg)
- Participant has hemoglobin of ≤ 16 grams per deciliter (g/dL) at the time of study entry
- Participant has normal iron stores
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind, Placebo-controlled, Dose Escalation Study of the Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and minimum pharmacologically active dose of peginesatide in Healthy Volunteers.
Read the detailed description
This was a Phase 1, double-blind, placebo-controlled trial of peginesatide, an erythropoiesis stimulating agent, with approximately 7 treatment cohorts and 7 healthy volunteer participants per cohort. In each cohort of 7 participants, a ratio of 5:2 participants was randomly assigned to receive a single dose of peginesatide or placebo, respectively, administered as an intravenous infusion. Planned peginesatide dose levels were to escalate by cohort. The study was conducted at a single clinical center.
- Conditions
- Anemia, Chronic Kidney Disease, Chronic Renal Failure, Cancer
- Being tested
- Placebo, peginesatide
- Keywords
- anemia, chronic kidney disease, CKD, chronic renal failure, CRF, erythropoietin, EPO, erythropoiesis stimulating agent, ESA, Hematide™, hemoglobin, Hb, Hgb, Omontys, peginesatide, red blood cell, red blood cell production
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic, Kidney Failure, Chronic, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
peginesatideDrug
Also called Omontys, Hematide, AF37702 Injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Single injection administered intravenously Receives: Drug: Placebo |
| Peginesatide 0.025 mg/kg | Experimental | Single peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously. Receives: Drug: peginesatide |
| Peginesatide 0.05 mg/kg | Experimental | Single peginesatide dose of 0.05 mg/kg administered intravenously. Receives: Drug: peginesatide |
| Peginesatide 0.10 mg/kg | Experimental | Single peginesatide dose of 0.10 mg/kg administered intravenously. Receives: Drug: peginesatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: 28 Days
Secondary outcomes (2)
PK parameters
Measured: 28 Days
Pharmacodynamic (PD) parameters
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2004 (estimated)
- Study startAug 2004
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affymax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Affymax, Study director, Affymax, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097747
- Sponsor's protocol ID
- AFX01-0401
- Other IDs
- 2004-001655-11, 2004
- Status last verified
- Dec 2012
- First submitted
- 30 Nov 2004
- Last updated
- 21 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Placebo-controlled, Dose Escalation Study of the Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00097747
- Acronym / sponsor ID
- AFX01-0401
- Conditions
- Anemia, Chronic Kidney Disease, Chronic Renal Failure, Cancer
- Keywords
- anemia, chronic kidney disease, CKD, chronic renal failure, CRF, erythropoietin, EPO, erythropoiesis stimulating agent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AffymaxIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 1 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and minimum pharmacologically active dose of peginesatide in Healthy Volunteers.
Detailed description
This was a Phase 1, double-blind, placebo-controlled trial of peginesatide, an erythropoiesis stimulating agent, with approximately 7 treatment cohorts and 7 healthy volunteer participants per cohort. In each cohort of 7 participants, a ratio of 5:2 participants was randomly assigned to receive a single dose of peginesatide or placebo, respectively, administered as an intravenous infusion. Planned peginesatide dose levels were to escalate by cohort. The study was conducted at a single clinical center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSingle injection administered intravenously |
| Peginesatide 0.025 mg/kg | Experimental | Drug: peginesatideSingle peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously. |
| Peginesatide 0.05 mg/kg | Experimental | Drug: peginesatideSingle peginesatide dose of 0.05 mg/kg administered intravenously. |
| Peginesatide 0.10 mg/kg | Experimental | Drug: peginesatideSingle peginesatide dose of 0.10 mg/kg administered intravenously. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo | Drug | Placebo |
| peginesatideAlso: Omontys, Hematide, AF37702 Injection | Drug | Peginesatide 0.025 mg/kg, Peginesatide 0.05 mg/kg, Peginesatide 0.10 mg/kg |
Primary outcome
Adverse events
Time frame: 28 Days
2 secondary outcomes
PK parameters
Time frame: 28 Days
Pharmacodynamic (PD) parameters
Time frame: 28 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Affymax study director
Affymax, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing peginesatide in people with Anemia and Chronic Kidney Disease, run by Affymax at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 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.
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?
Adverse events (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2012.