Kidney DiseasePhase 3NCT00093977
Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease
A Phase 3 study testing darbepoetin alfa SF in people with Kidney Disease and Chronic Kidney Disease, run by Amgen.
Trial summary
The purpose of this study is to determine whether darbepoetin alfa manufactured by the current "roller bottle" technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Disease, Chronic Kidney Disease
- What is being tested?
- darbepoetin alfa SF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Jan 2007
- Phase
- Phase 3
- 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
- Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis
- Anemic
- Currently on erythropoietic therapy
- Controlled hypertension
- Clinically stable
Who cannot join
None listed.
About this study
Official title: An Open-label, Single-Arm Study to Assess the Safety of Darbepoetin Alfa Manufactured by a Serum Free Bioreactor Technology in Subjects With Chronic Kidney Disease
The purpose of this study is to determine whether darbepoetin alfa manufactured by the current "roller bottle" technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile.
- Conditions
- Kidney Disease, Chronic Kidney Disease
- Being tested
- darbepoetin alfa SF
- Keywords
- Chronic Kidney Disease, Dialysis, Anemia, Nephrology
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
darbepoetin alfa SFDrug
Frequency of dosing depends on frequency at randomization:
rHuEPO QW = darbepoetin alfa SF Q2W (dosing conversion table in protocol) rHuEPO biw or tiw = darbepoetin alfa SF QW (dosing conversion table in protocol) darbepoetin alfa RB = darbepoetin alfa SF at same dose and frequency PFS 10, 15, 20, 30, 40, 50, 60, 80, 100, 150, 200 or 300 mcg; Hb maintained between 11.0 - 13.0 g/dL
| Study group | Role | What they receive |
|---|---|---|
| darbepoetin alfa SF | Experimental | Not described Receives: Drug: darbepoetin alfa SF |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether darbepoetin alfa manufactured by a roler bottle technology (darbepoetin alfa RB) and darbepoetin alfa manufactured by a serum free process (darbepoetin alfa SF) have a comparable safety profile
Measured: Entire Study
Secondary outcomes (1)
To characterize laboratory parameters in subjects with CKD
Measured: Entire Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2004 (estimated)
- Study startOct 2004
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093977
- Sponsor's protocol ID
- 20040180
- Status last verified
- May 2013
- First submitted
- 7 Oct 2004
- Last updated
- 24 May 2013
- Results posted
- No
Publications
Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. J Manag Care Pharm. 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741.
PubMed 19954265
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-Arm Study to Assess the Safety of Darbepoetin Alfa Manufactured by a Serum Free Bioreactor Technology in Subjects With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00093977
- Acronym / sponsor ID
- 20040180
- Conditions
- Kidney Disease, Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Dialysis, Anemia, Nephrology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 11 Oct 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 determine whether darbepoetin alfa manufactured by the current "roller bottle" technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| darbepoetin alfa SF | Experimental | Drug: darbepoetin alfa SF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis
- Anemic
- Currently on erythropoietic therapy
- Controlled hypertension
- Clinically stable
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| darbepoetin alfa SFFrequency of dosing depends on frequency at randomization: rHuEPO QW = darbepoetin alfa SF Q2W (dosing conversion table in protocol) rHuEPO biw or tiw = darbepoetin alfa SF QW (dosing conversion table in protocol) darbepoetin alfa RB = darbepoetin alfa SF at same dose and frequency PFS 10, 15, 20, 30, 40, 50, 60, 80, 100, 150, 200 or 300 mcg; Hb maintained between 11.0 - 13.0 g/dL | Drug | darbepoetin alfa SF |
Primary outcome
To determine whether darbepoetin alfa manufactured by a roler bottle technology (darbepoetin alfa RB) and darbepoetin alfa manufactured by a serum free process (darbepoetin alfa SF) have a comparable safety profile
Time frame: Entire Study
1 secondary outcome
To characterize laboratory parameters in subjects with CKD
Time frame: Entire Study
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 24 May 2013.
- Results publication: PubMed 19954265Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. J Manag Care Pharm. 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- FDA-approved Drug LabelingLink provided by the sponsor.
Related trials for Kidney Disease
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing darbepoetin alfa SF in people with Kidney Disease and Chronic Kidney Disease, run by Amgen.
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 5 inclusion and 0 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 24 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To determine whether darbepoetin alfa manufactured by a roler bottle technology (darbepoetin alfa RB) and darbepoetin alfa manufactured by a serum free process (darbepoetin alfa SF) have a comparable safety profile (time frame: Entire Study). 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 NCT00093977, which also lists 1 linked publication.
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 24 May 2013.