Chronic Kidney DiseasePhase 4NCT00369733
STAAR-3 Clinical Study
A Phase 4 study testing Darbepoetin alfa in people with Chronic Kidney Disease and Chronic Renal Insufficiency, run by Amgen.
Trial summary
To assess the effect of Aranesp on the hemoglobin (Hgb) of CRI subjects who are recombinant human erythropoietin (rHuEPO)-naïve or converting from rHuEPO therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Chronic Renal Insufficiency, Kidney Disease
- What is being tested?
- Darbepoetin alfa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 443 participants
- Where
- No sites listed yet
- Study dates
- May 2002to May 2004
- Phase
- Phase 4
- 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
- diagnosis of CRI and not receiving dialysis therapy (must be predialysis)
- measured or estimated (using the Cockcroft-Gault formula) creatinine clearance (CrCl) of ≤ 70 mL/min, or GFR ≤ 60 mL/min (using the MDRD formula):
- Cockcroft-Gault formula: CrCl = (140 minus age in years) x (body weight in kg) serum creatinine (mg/dL) x 72.0. For women, the value will be multiplied by 0.85
- MDRD formula: GFR = 170 x [SCr]-0.999 x [Age]-0.167 x [0.762 if subject is female] x [1.180 if subject is black] x [SUN]-0.170 x [SAlb]-0.318
- (if subject is not already receiving rHuEPO therapy) mean Hgb < 11 g/dL during the screening/baseline period
- for subjects currently receiving rHuEPO therapy, the subject must have: a stable rHuEPO dose for the past month; and a rHuEPO frequency of once weekly.
Show all 11Show fewer
- white blood cell and platelet counts within normal limits
- serum vitamin B12 and folate levels above the lower limit of normal range
- transferrin saturation (TSAT) ≥ 20% during the screening period
- availability for follow-up assessments
- subject must be able to comprehend and be willing to, or have legally accepted representative, give written informed consent for participation in the study
Who cannot join
- scheduled to initiate dialysis
- uncontrolled hypertension (diastolic blood pressure > 105 mm Hg or systolic blood pressure of > 180 mm Hg during the screening/baseline period on two separate measurements)
- clinically unstable in the judgment of the investigator (eg, subject is in the intensive care unit, immediately post-myocardial infarction, etc)
- scheduled to receive a living donor kidney transplant
- treatment of grand mal epilepsy within the past 6 months
- moderate to severe congestive heart failure (NYHA class III or IV)
Show all 21Show fewer
- clinical evidence of severe secondary hyperparathyroidism (parathyroid hormone level > 1500 pg/mL)
- severe active chronic inflammatory process (eg, ulcerative colitis, peptic ulcer disease, rheumatoid arthritis, etc)
- currently receiving antibiotic therapy for systemic infection (enrollment may be postponed until the course of antibiotics has ended)
- known aspartate aminotransferase (AST) or alanine aminitransferase (ALT) greater than 3 times the upper limit of the normal range on more than one occasion within three months prior to screening
- known positive HIV antibody or hepatitis B surface antigen
- clinical evidence of current malignancy and/or receiving chemotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia
- active bleeding or RBC transfusion within eight weeks of enrollment
- androgen therapy within four weeks before enrollment
- known hematologic disease (eg, sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma; hemolytic anemia, etc)
- any condition that is likely to affect subject compliance
- currently or previously (within 30 days) enrolled in investigational device or drug trial(s) or receiving investigational agent(s)
- the exception to this is if the subject was enrolled in another Aranesp™ or rHuEPO protocol
- pregnant or breast feeding women (women of child-bearing potential must be using contraceptive precautions)
- women planning to have a child during the study period
- known hypersensitivity to the active substance or any of the excipients
About this study
Official title: Disease/Case Management of Patients Receiving ARANESP™ (Darbepoetin Alfa) to Treat the Anemia of Chronic Renal Insufficiency (CRI)
To assess the effect of Aranesp on the hemoglobin (Hgb) of CRI subjects who are recombinant human erythropoietin (rHuEPO)-naïve or converting from rHuEPO therapy.
Read the detailed description
To assess the effect of Aranesp on the hemoglobin of CRI subjectswho are recombinant human erythropoetin (rHuEPO)-naïve or converting from rHuEPO therapy and to assess the association between subject self-reported health-related quality of life (HRQoL) as it relates to Hgb concentration and glomerular filtration rate (GFR) in subjects who were rHuEPO-naïve prior to study enrollment.
To characterize the health-related resource utilization of subjects with CRI. To characterize the subject satisfaction with Aranesp™ compared to previous rHuEPO therapy.
To characterize iron treatment in subjects with CRI. To evaluate the extent to which implementation of case management contributes to achieving the desired clinical objectives.
To assess the safety profile of Aranesp™ therapy in subjects with CRI.
- Conditions
- Chronic Kidney Disease, Chronic Renal Insufficiency, Kidney Disease, Pre-dialysis, Pre-ESRD
- Being tested
- Darbepoetin alfa
- Keywords
- Aranesp, Anemia, Kidney Disease, Hemoglobin, darbepoetin alfa, QoL
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin alfaDrug
Also called Aranesp
Darbepoetin alfa adminstered SC every other week to acheive a Hb not to exceed 12 g/dL
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Aranesp adminsitered every other week for 52 weeks Receives: Drug: Darbepoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean hemoglobin during the evaluation period.
Measured: 52 weeks
Secondary outcomes (5)
Change in hemoglobin throughout the study
Measured: 52 weeks
HRQoL scores of rHuEPO-naïve subjects measured at baseline, week 12, week 24, and end of study
Measured: 52 weeks
Health-related resource utilization, measured every 4 weeks, throughout the study
Measured: 52 weeks
Patient satisfaction scores of subjects previously on rHuEPO therapy, measured at baseline and week 12
Measured: 12 weeks
Iron requirement (dose, frequency, and route) of subjects during the study
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startMay 2002
- Primary completionMar 2004
- Study completionMay 2004
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 Chronic 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369733
- Sponsor's protocol ID
- 20010243
- Status last verified
- Feb 2010
- First submitted
- 24 Aug 2006
- Last updated
- 19 Feb 2010
- Results posted
- No
Publications
Abu-Alfa AK, Sloan L, Charytan C, Sekkarie M, Scarlata D, Globe D, Audhya P. The association of darbepoetin alfa with hemoglobin and health-related quality of life in patients with chronic kidney disease not receiving dialysis. Curr Med Res Opin. 2008 Apr;24(4):1091-100. doi: 10.1185/030079908x280653. Epub 2008 Mar 6.
PubMed 18328118
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease/Case Management of Patients Receiving ARANESP™ (Darbepoetin Alfa) to Treat the Anemia of Chronic Renal Insufficiency (CRI)
- ClinicalTrials.gov ID
- NCT00369733
- Acronym / sponsor ID
- 20010243
- Conditions
- Chronic Kidney Disease, Chronic Renal Insufficiency, Kidney Disease, Pre-dialysis, Pre-ESRD
- Keywords
- Aranesp, Anemia, Kidney Disease, Hemoglobin, darbepoetin alfa, QoL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Mar 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 29 Aug 2006 (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.
To assess the effect of Aranesp on the hemoglobin (Hgb) of CRI subjects who are recombinant human erythropoietin (rHuEPO)-naïve or converting from rHuEPO therapy.
Detailed description
To assess the effect of Aranesp on the hemoglobin of CRI subjectswho are recombinant human erythropoetin (rHuEPO)-naïve or converting from rHuEPO therapy and to assess the association between subject self-reported health-related quality of life (HRQoL) as it relates to Hgb concentration and glomerular filtration rate (GFR) in subjects who were rHuEPO-naïve prior to study enrollment.
To characterize the health-related resource utilization of subjects with CRI. To characterize the subject satisfaction with Aranesp™ compared to previous rHuEPO therapy.
To characterize iron treatment in subjects with CRI. To evaluate the extent to which implementation of case management contributes to achieving the desired clinical objectives.
To assess the safety profile of Aranesp™ therapy in subjects with CRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: Darbepoetin alfaAranesp adminsitered every other week for 52 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- diagnosis of CRI and not receiving dialysis therapy (must be predialysis)
- measured or estimated (using the Cockcroft-Gault formula) creatinine clearance (CrCl) of ≤ 70 mL/min, or GFR ≤ 60 mL/min (using the MDRD formula):
- Cockcroft-Gault formula: CrCl = (140 minus age in years) x (body weight in kg) serum creatinine (mg/dL) x 72.0. For women, the value will be multiplied by 0.85
- MDRD formula: GFR = 170 x [SCr]-0.999 x [Age]-0.167 x [0.762 if subject is female] x [1.180 if subject is black] x [SUN]-0.170 x [SAlb]-0.318
- (if subject is not already receiving rHuEPO therapy) mean Hgb < 11 g/dL during the screening/baseline period
Key exclusion criteria (21 listed)
- scheduled to initiate dialysis
- uncontrolled hypertension (diastolic blood pressure > 105 mm Hg or systolic blood pressure of > 180 mm Hg during the screening/baseline period on two separate measurements)
- clinically unstable in the judgment of the investigator (eg, subject is in the intensive care unit, immediately post-myocardial infarction, etc)
- scheduled to receive a living donor kidney transplant
- treatment of grand mal epilepsy within the past 6 months
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 alfaAlso: AranespDarbepoetin alfa adminstered SC every other week to acheive a Hb not to exceed 12 g/dL | Drug | Single arm |
Primary outcome
Mean hemoglobin during the evaluation period.
Time frame: 52 weeks
5 secondary outcomes
Change in hemoglobin throughout the study
Time frame: 52 weeks
HRQoL scores of rHuEPO-naïve subjects measured at baseline, week 12, week 24, and end of study
Time frame: 52 weeks
Health-related resource utilization, measured every 4 weeks, throughout the study
Time frame: 52 weeks
Patient satisfaction scores of subjects previously on rHuEPO therapy, measured at baseline and week 12
Time frame: 12 weeks
Iron requirement (dose, frequency, and route) of subjects during the study
Time frame: 52 weeks
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 19 Feb 2010.
- Derived from this study: PubMed 18328118Abu-Alfa AK, Sloan L, Charytan C, Sekkarie M, Scarlata D, Globe D, Audhya P. The association of darbepoetin alfa with hemoglobin and health-related quality of life in patients with chronic kidney disease not receiving dialysis. Curr Med Res Opin. 2008 Apr;24(4):1091-100. doi: 10.1185/030079908x280653. Epub 2008 Mar 6.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
Related trials for Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Not yet recruiting
Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
End-Stage Renal Disease, Renal Dialysis
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
RecruitingPhase 4
Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus
Chronic Kidney Diseases, Type 2 Diabetes Mellitus
Enrolling by invitationObservational study
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
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 4 study testing Darbepoetin alfa in people with Chronic Kidney Disease and Chronic Renal Insufficiency, 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 11 inclusion and 21 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 19 Feb 2010. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Mean hemoglobin during the evaluation period. (time frame: 52 weeks). 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 NCT00369733, 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 19 Feb 2010.