Minnie Sarwal
Pediatric Study of Darbepoeitin Alfa weekly versus every two weeks to correct anemia in children with Chronic Kidney disease.
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
To test the proportion of subjects achieving a Hb value greater than or equal to 10.0 g/dL at any time-point after the first dose during the study is greater than 0.8 when administered de novo darbepoeitin alfa QW for treatment of anemia in pediatric CKD subjects receiving and not receiving dialysis. To test if the proportion of subjects achieving a Hb value greater than or equal to 10.0 g/dL at any time point after the fist dose during the study is greater than 0.8 when administered de novo darbepoeitin alfa Q2W for treatment of anemia in pediatric CKD subjects receiving and not receiving dialysis.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Darbepoeitin alfa QW
- Drug: Darbepoeitin alfa Q2W
Phase:
Phase 3Eligibility
Ages Eligible for Study:
1 years to 18 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Before any study-specific procedure, the appropriate written informed consent must be obtained. In addition to written informed consent, the assent of the child also must be obtained if requested by the IRB/independent ethics committee.
-Diagnosis of CKD defined as:
*Requiring dialysis (PD or HD)
*Not requiring dialysis-CKD stage 3-4
with an estimated GFR
<60mL/min/1.73m2 and
15ml/min/1.73m2 (Schwartz
Equation)
-Ages 1 year to 18 years
-Two consecutive screening Hb values (taken at least 7 days apart during the screening period) must be <10.0 g/dL
-Transferrin saturation (Tsat) 20%
-Clinically stable, in the judgement of the investigator.
Key Exclusion Criteria:
Subjects who fulfill any of the following criteria ar eineligible for the study:
-Anticipating or scheduled for a living related donor kidney transplant, or a prior recipient of a kidney transplant.
-Prior history (within 12 weeks before enrollment) of cardiovascular events icluding:
*acute myocardial ischemia
*hospitalization for congestive heart
failure
*myocardial infarction
*stroked or transient ischemic attack
-Hematologic disease (eg sickle cell disease, myelodysplastic syndromes, hematologic malignancy); myeloma; hemolytic anemia; thalassemia.
-Upper or lower GI bleeding within the prior 6 months
Uncontrolled hypertension defined as stage 2 hypertension or greater. This is defined as a systolic or diastolic blood pressure value greater than the 99th percentile + 5mmHg for a subject's age.
-Any erythropoietic-stimulating agent (ESA use (eg Aranesp, EPOGEN, Procrit) within 12 weeks before randomization.
-History of seizure
-Major surgery within 12 weeks prior to randomization (excluding vascular access surgery)
-Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia.
-RBC transfusions withing 12 weeks prior to randomization
-Androgen therapy within 8 weeks prior to randomization
-Currently receiving antibiotic therapy for systemic infection.
-Prior history (within 6 months prior to randomiozation) of thromboembolism (eg deep bein thrombosis or pulmonary embolism)
-Peritoneal dialysis subjects with an episode of peritonitis within 30 days prior to randomization
-Pregnant or breast feeding, or planning to become pregnant withing fur weeks after the end of treatment. Females who have reached menarch must have a negative serum pregnancy test (or definitive evidence to demonstrate lack of pregnancy) within 21 days prior to randomization, unless there is a documented history of amenorrhea.
-Not willing to use effective contraception during treatment and for 1 month after the end of treatment.
-Other investigational procedures are excluded.
-Treatment with an investigational product or device within 30 days before randomization or scheduled to receive an investigational product other than those specified by this protocol during the course of this study.
-Has known sensitivity to any of the products to ba dministered during dosing.
-Subject or parent/legal guardian has any kind of disorder that compromises ability of the subject or parent/legal guardian to give written informed consent and or to comply with study procedure.
-Subject is currently taking immunosuppressive agents.
Additional Study Details
Official Title:
A Multi-Center, Double-Blind, Randomized Study Evaluating de Novo Weekly and Once Every Two Week Darbepoeitin Alfa Dosing For The Correction Of Anemia In Pediatric Subjects With Chronic Kidney Disease Receiving And Not Receiving DialysisAnticipated start date:
11/1/2008Lead Sponsor:
AmgenInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
EfficacyPrimary Outcomes:
- Achieving a Hb value of 11.0 g/dL at any time point during the study when administered de novo darvepoeitin alfa.
Secondary Outcomes:
- Hb value at every time point
- Darbepoeitin alfa doses over the duration of the study
- Time to first Hb value 11.0 g/dL
- Dose at first Hb value 11.0 g/dL
Total Number to be Enrolled:
150Total Number to be Enrolled at Stanford:
0More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
9/25/2008PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
Help