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Anemia clinical trials

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NCT ID: NCT00462384 Completed - Anemia Clinical Trials

A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Patients With Chronic Kidney Disease.

Start date: February 2008
Phase: Phase 3
Study type: Interventional

This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting dose of 1.2 micrograms/kg). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00456053 Completed - Renal Anemia Clinical Trials

A Randomized Study of the Safety and Efficacy of FG-2216 in Subjects With Renal Anemia Not Requiring Dialysis and Not Receiving Recombinant Human Erythropoietin

Start date: December 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the safety and efficacy of FG-2216 in the treatment of patients with renal anemia who are not receiving erythropoietin and who are not on dialysis.

NCT ID: NCT00455312 Completed - Aplastic Anemia Clinical Trials

Stem Cell Transplant (SCT) for Dyskeratosis Congenita or SAA

Start date: August 2007
Phase: Phase 2/Phase 3
Study type: Interventional

Transplantation with stem cells is a standard therapy in many centers around the world. Previous experience with stem cell transplantation therapy for leukemias, lymphomas, other cancers, aplastic anemia and other non-malignant diseases, has led to prolonged disease-free survival or cure for some patients. However, the high doses of pre-transplant radiation and chemotherapy drugs used, and the type of drugs used, often cause many side effects that are intolerable for some patients. Slow recovery of blood counts is a frequent complication of high dose pre-transplant regimens, resulting in a longer period of risk for bleeding and infection plus a longer time in the hospital. Recent studies have shown that using lower doses of radiation and chemotherapy (ones that do not completely kill all of the patient's bone marrow cells) before blood or bone marrow transplant, may be a better treatment for high risk patients, such as those with Dyskeratosis Congenita (DC) or Severe Aplastic Anemia(SAA). These low dose transplants may result in shorter periods of low blood counts, and blood counts that do not go as low as with traditional pre-transplant radiation and chemotherapy. Furthermore, in patients with Dyskeratosis Congenita or SAA, the stem cell transplant will replace the blood forming cells with healthy cells. It has recently been shown that healthy marrow can take and grow after transplantation which uses doses of chemotherapy and radiation that are much lower than that given to patients with leukemia. While high doses of chemotherapy and radiation may be necessary to get rid of leukemia, this may not be important to patients with Dyskeratosis Congenita or SAA. The purpose of this research is to see if this lower dose chemotherapy and radiation regimen followed by transplant is a safe and effective treatment for patients with Dyskeratosis Congenita or SAA.

NCT ID: NCT00453388 Completed - Fanconi Anemia Clinical Trials

Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation Followed by Donor Bone Marrow Transplant, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Fanconi Anemia

Start date: February 2007
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well total-body irradiation (TBI) works when given together with fludarabine phosphate and cyclophosphamide followed by donor bone marrow transplant, mycophenolate mofetil, and cyclosporine in treating patients with Fanconi anemia (FA). Giving low doses of chemotherapy, such as fludarabine phosphate and cyclophosphamide, and TBI before or after a donor bone marrow transplant helps stop the growth of abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.

NCT ID: NCT00446576 Completed - Anemia Clinical Trials

The Effect of Epoetin Alfa on Cardiac Function and Quality of Life in Patients With Early Renal ((Kidney) Disease

Start date: November 1999
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess whether maintaining hemoglobin (Hb) levels at normal or sub-normal levels with Epoetin Alfa can influence the health status, left ventricular mass and quality of life of early renal insufficiency subjects without additional safety concerns.

NCT ID: NCT00442793 Completed - Anemia Clinical Trials

A Study Comparing Mircera and Epoetin Beta for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

Start date: May 2007
Phase: Phase 3
Study type: Interventional

This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00442702 Completed - Anemia Clinical Trials

A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.

Start date: September 2007
Phase: Phase 3
Study type: Interventional

This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00440557 Completed - Anemia Clinical Trials

An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease

Start date: September 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that once weekly and once every-2-weeks treatment with epoetin alfa, in patients with anemia associated with chronic kidney disease, is not less effective than the approved treatment with epoetin alfa that is given 3 times weekly with respect to changes in hemoglobin.

NCT ID: NCT00440466 Completed - Anemia Clinical Trials

PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients

Start date: July 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks treatment with epoetin alfa, a drug that increases red blood cell production, in patients with anemia associated with chronic kidney disease, is not less effective than treatment with epoetin alfa that is given once a week

NCT ID: NCT00439595 Completed - Anaemia Clinical Trials

A Trial of 2 'Point of Care' Diagnostic Methods to Improve Detection and Treatment of Anaemia in African Children

EARS
Start date: February 2007
Phase: N/A
Study type: Interventional

A high proportion of children under the age of 5 years and pregnant women in Tanzania is anaemic, particularly in areas of high malaria transmission. The symptoms of anaemia are often non-specific or absent and clinical judgement is generally insensitive in estimating Hb levels, especially in infants who are assessed by basic grade health staff. Thus while treatment for the common causes of anaemia is available, many cases are not treated due to difficulties in recognising anaemia. New diagnostic tools can increase the sensitivity of anaemia detection compared to clinical diagnosis but no studies have demonstrated their effectiveness in increasing case-detection and treatment of anaemic patients at the first level of healthcare. In addition, the costs of their use in relation to any increase in numbers of cases treated are not known and this knowledge is needed to guide public health decisions. Two methods of measuring anaemia are currently suitable for use at the first level of care; Copack Haemoglobin colour scale (HBCS) and Hemocue portable photometry. We propose to compare the effectiveness in basic health facilities of these 2 simple diagnostic tools compared to control dispensaries (current practice) in increasing rates of detection and treatment of anaemia in children under the age of 5 years and pregnant women over the course of 1 year in a cluster-randomised trial in 30 dispensaries in a malaria-endemic area of NE Tanzania.