Chronic Kidney Disease Clinical Trial
Official title:
Disease/Case Management of Patients Receiving ARANESP™ (Darbepoetin Alfa) to Treat the Anemia of Chronic Renal Insufficiency (CRI)
Verified date | February 2010 |
Source | Amgen |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 443 |
Est. completion date | May 2004 |
Est. primary completion date | March 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. - 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 Exclusion Criteria: - 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) - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Amgen |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean hemoglobin during the evaluation period. | 52 weeks | No | |
Secondary | Change in hemoglobin throughout the study | 52 weeks | No | |
Secondary | HRQoL scores of rHuEPO-naïve subjects measured at baseline, week 12, week 24, and end of study | 52 weeks | No | |
Secondary | Health-related resource utilization, measured every 4 weeks, throughout the study | 52 weeks | No | |
Secondary | Patient satisfaction scores of subjects previously on rHuEPO therapy, measured at baseline and week 12 | 12 weeks | No | |
Secondary | Iron requirement (dose, frequency, and route) of subjects during the study | 52 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
Terminated |
NCT04043026 -
The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
|
||
Completed |
NCT05318014 -
Low-protein Formula Supplements in Chronic Kidney Disease
|
N/A | |
Active, not recruiting |
NCT06071065 -
Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients
|
N/A | |
Completed |
NCT02878317 -
Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
|
||
Not yet recruiting |
NCT06039254 -
Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function
|
Phase 1 | |
Recruiting |
NCT03160326 -
The QUALITY Vets Project: Muscle Quality and Kidney Disease
|
||
Completed |
NCT02756520 -
Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
|
||
Withdrawn |
NCT02885545 -
The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial
|
Phase 4 | |
Completed |
NCT02875886 -
DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease
|
Phase 4 | |
Completed |
NCT02836574 -
A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease
|
Phase 2 | |
Completed |
NCT02896309 -
The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity
|
N/A | |
Completed |
NCT02888171 -
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
|
N/A | |
Active, not recruiting |
NCT02483039 -
Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization
|
N/A | |
Terminated |
NCT02543177 -
Optimised Procedure in Patients With NSTEMI and CKD
|
N/A | |
Completed |
NCT02992548 -
Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease
|
Phase 4 | |
Completed |
NCT02369549 -
Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease
|
Phase 3 | |
Recruiting |
NCT02205944 -
Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes
|
N/A | |
Active, not recruiting |
NCT02231138 -
Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease
|
Phase 4 |