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| autoid | 98 |
| crg_id | CRG010600034 |
| titleoftrial | Efficacy of Bi-Weekly versus Four-weekly Low Dose Subcutaneous Darbepoetin-Alpha for the Maintenance Treatment of Anemia in Peritoneal Dialysis Patients: An Open-Label Randomized Study |
| acronymnoftrial | Darbepoetin in peritoneal dialysis patients |
| website | http:// |
| identificationno | |
| leadprefix | Prof |
| leadsurname | Li |
| leadgivennames | Philip KT |
| leadposition | Consultant and Chief of Nephrology |
| leaddepartment | Department of Medicine & Therapeutics |
| leadorganisation | Prince of Wales Hospital, The Chinese University of Hong Kong |
| leadaddress | 30-32 Ngan Shing Street, Shatin, Hong Kong |
| leademail | philipli@cuhk.edu.hk |
| leadphone | +852 2632 3129 |
| leadfax | +852 2637 5396 |
| leadsuffix | |
| contactprefix | Dr |
| contactsurname | Kwan |
| contactgivennames | Bonnie CH |
| contactposition | Fellow |
| contactdepartment | Department of Medicine & Therapeutics |
| contactorganisation | Prince of Wales Hospital, The Chinese University of Hong Kong |
| contactaddress | 30-32 Ngan Shing Street, Shatin, Hong Kong |
| contactemail | bonniekwan@cuhk.edu.hk |
| contactphone | +852 2632 3133 |
| contactfax | +852 2637 5396 |
| funding | |
| otherfunding | drug was provided by drug company free of charge |
| fundingnameofsponsors | |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | no |
| proposedstart | June 2004 |
| actualstart | Sept 2004 |
| proposedcompletiondate | June 2005 |
| actualcompletiondate | June 2005 |
| multi_center_study | no |
| numberofcentres | |
| multi_national_study | no |
| countrycentres | Hong Kong |
| researchquestion | To compare the efficacy, safety, and patient acceptability of four-weekly versus standard bi-weekly subcutaneous darbepoetin for the treatment of anemia in peritoneal dialysis patients. |
| study_status_recruitment | no_longer_recruiting |
| study_status_recruitment_follow | completed |
| healthcarecondition | end stage renal failure on peritoneal dialysis |
| intervention1 | darbepoetin-alpha (Aranesp) bi-weekly |
| intervention2 | darbepoetin-alpha (Aranesp) 4-weekly |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | >18 years old |
| totalrecruitment | 60-70 |
| inclusion | a) clinically stable adult patients (> 18 years old) on PD for at least 3 months; and b) on subcutaneous rHuEPO with stable dosage for 3 months and c) with stable Hb level for 3 months (defined as Hb level fluctuating within 1 g/dL (10g/L)) |
| exclusion | blood transfusion within 3 months, gastrointestinal bleeding or other bleeding episodes necessitating treatment within 8 weeks, known hematological diseases, poorly controlled hypertension, patients who are pregnant or breast feeding and patients with life expectancy less than 6 months |
| primaryoutcomes | change in hemoglobin level over 24 weeks |
| secondaryoutcomes | changes in the MCV, the number of units of blood transfusion required and changes in blood pressure and anti-hypertensive medications |
| reference |