Chronic Kidney Disease, Receiving Dialysis Clinical Trial
Official title:
An Observational Study of South African Dialysis Patients Treated With Aranesp
| Verified date | May 2015 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | South Africa: Medicines Control Council |
| Study type | Observational |
An observational study to describe the treatment of anaemia in patients with chronic kidney disease, who are receiving dialysis treatment at selected study centres in South Africa.
| Status | Terminated |
| Enrollment | 28 |
| Est. completion date | February 2014 |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Adult patients undergoing chronic haemodialysis or peritoneal dialysis - Commenced Aranesp therapy 3-6 months prior to enrolment - Erythropoiesis stimulating agent (ESA) naive or treated with another ESA prior to commencing Aranesp - Informed consent obtained Exclusion Criteria: - Received Aranesp in an interventional study within 6 months prior to start of observation period - Receive investigational product during the observation period |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| South Africa | Research Site | Cape Town | Western Cape |
| South Africa | Research Site | Durban | |
| South Africa | Research Site | Glenwood | KwaZulu-Natal |
| South Africa | Research Site | Kimberley | |
| South Africa | Research Site | Lenasia | |
| South Africa | Research Site | Roodepoort | |
| South Africa | Research Site | Umhlanga Rocks | KwaZulu-Natal |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
South Africa,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Haemoglobin Concentration | Due to the premature termination of the study no outcome measure data were analyzed. | Each 4-week period for the duration of the study period (15 months) | No |
| Secondary | Hemoglobin Excursions | Hemoglobin excursions defined as hemoglobin <10g/dL and >12g/dL. Due to the premature termination of the study no outcome measure data were analyzed. | Over the 15-month observation period | No |
| Secondary | Hemoglobin Within the Range 10-12 g/dL Over Time | Due to the premature termination of the study no outcome measure data were analyzed. | On a continuous basis over the 15-month observation period | No |
| Secondary | Erythropoiesis Stimulating Agent (ESA) Usage | Due to the premature termination of the study no outcome measure data were analyzed. | Over the 15-month observation period | No |
| Secondary | ESA/Aranesp Dose Ratio | Ratio of the calculated mean weekly dose equivalent of an ESA administered immediately prior to conversion to treatment with Aranesp, to the calculated mean weekly dose equivalent of the first dose of Aranesp administered at commencement. Not applicable to participants who were ESA-naive at time of Aranesp commencement. Due to the premature termination of the study no outcome measure data were analyzed. |
Day of commencement of Aranesp | No |
| Secondary | Iron Therapy Use | Due to the premature termination of the study no outcome measure data were analyzed. | Over the 15-month observation period | No |
| Secondary | Use of Concomitant Therapies: Immunosuppressants, Cardiovascular Medications, Secondary Hypoparathyroidism Medications, Anti-retroviral Therapy | Due to the premature termination of the study no outcome measure data were analyzed. | At each 12-week interval over the observation period | No |
| Secondary | C-Reactive Protein, Albumin, Transferrin Saturation and Serum Ferritin Concentration | Due to the premature termination of the study no outcome measure data were analyzed. | Over the 15-month observation period | No |
| Secondary | Number of Red Blood Cell Transfusions | Due to the premature termination of the study no outcome measure data were analyzed. | Over the 15-month observation period | No |
| Secondary | Number of Hospitalisations | Due to the premature termination of the study no outcome measure data were analyzed. | Over the 15-month observation period | No |