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Chronic Kidney DiseasePhase 4NCT00368901

STAAR-2 Clinical Study

A Phase 4 study testing Darbepoetin alfa in people with Chronic Kidney Disease and Chronic Renal Insufficiency, run by Amgen.

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

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
What is being tested?
Darbepoetin alfa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
618 participants
Where
No sites listed yet
Study dates
Jan 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

  • ≥ 18 years old
  • 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] -0.170SAlb]-0.318
  • mean Hgb < 11 g/dL during the screening/baseline period (if subject is not already receiving rHuEPO therapy)
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  • 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.
  • 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)
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  • 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 aminotransferase (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: A Multicenter Study Using Once Every Other Week Subcutaneous Administration of Aranesp™ (Darbepoetin Alfa) and Iron Guided Algorithms to Treat Subjects With 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 (Hgb) of CRI subjects who are recombinant human erythropoietin (rHuEPO)-naïve or converting from rHuEPO therapy. 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 assess the safety profile of Aranesp_ therapy in subjects with CRI

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

    Aranesp administered every other week SC titrated to not exceed Hb 12 g/dL

Study groups in NCT00368901
Study groupRoleWhat they receive
Single armExperimentalEvery other week dosing of Aranesp SC
Receives: Drug: Darbepoetin alfa

What is being measured

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

  1. Mean hemoglobin during the evaluation period

    Measured: 52 weeks

Secondary outcomes (5)

  1. Change in hemoglobin throughout the study

    Measured: 52 weeks

  2. HRQoL scores of rHuEPO-naïve subjects measured at baseline, week 12, week 24, and end of study

    Measured: 52 weeks

  3. Health-related resource utilization, measured every 4 weeks, throughout the study

    Measured: 52 weeks

  4. Patient satisfaction scores of subjects previously on rHuEPO therapy, measured at baseline and week 12

    Measured: 12 weeks

  5. 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.

  1. First posted29 Aug 2006 (estimated)
  2. Study startJan 2002
  3. Primary completionMar 2004
  4. Study completionMay 2004

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
618 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00368901
Sponsor's protocol ID
20010215
Status last verified
Mar 2010
First submitted
24 Aug 2006
Last updated
5 Mar 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

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 12 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 5 Mar 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 NCT00368901, 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 5 Mar 2010.

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STAAR-2 Clinical Study (NCT00368901) | AzTrials