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Anemia clinical trials

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NCT ID: NCT00244010 Completed - Anemia, Aplastic Clinical Trials

Partially Matched Stem Cell Transplantation for Patients With Refractory Severe Aplastic Anemia or Refractory Cytopenias

Start date: October 2005
Phase: N/A
Study type: Interventional

Due to an overall and disease free survival of 85% to 100%, allogeneic blood or bone marrow stem cell transplantation using an HLA matched sibling donor is the therapy of choice for patients with severe aplastic anemia (SAA). Unfortunately, only about 25% of patients have such a donor. For patients with SAA lacking a matched sibling donor, immunosuppressive therapy is the current treatment of choice. Approximately 70% of these patients have a complete or partial response to immunosuppressive therapy, achieving transfusion independence and/or growth factor independence. For the approximately 30% of patients who do not respond to immunosuppressive therapy or experience recurrence, alternative donor (matched unrelated, partially matched family member) transplantation is a treatment option. However, graft rejection and graft-versus-host-disease (GVHD) are significant barriers to success, decreasing event-free survival to 30% to 50%. This study offers stem cell transplantation using a partially matched family member (haploidentical) donor to those patients with no available HLA-matched sibling or matched unrelated donor. In an attempt to reduce GVHD and regimen-related toxicity while maintaining adequate engraftment, we plan to infuse a highly purified stem cell graft. The Miltenyi Biotec CliniMACS CD3 depletion system will be used to derive a defined allogeneic graft highly enriched for CD34+ hematopoietic cells and depleted of CD3+ T-lymphocytes from G-CSF mobilized, donor-derived peripheral blood stem cells. Patients 21 years of age and younger with refractory cytopenias are also eligible for this protocol as there are no other potentially curative therapies currently available for these conditions. The primary objective of this study is to evaluate the safety of transplantation using a haploidentical donor product engineered to targeted cell counts using the investigational CliniMACS device for patients with refractory severe aplastic anemia (SAA) or refractory cytopenias. The treatment plan would be considered unsafe if we can find this type of procedure is associated with a significantly higher treatment failure rate. Treatment failure is defined as any occurrence of the following events, overall grade III-IV acute GVHD, graft failure or death due to any cause within 100 days after transplant.

NCT ID: NCT00243399 Completed - Fanconi Anemia Clinical Trials

Oxandrolone for the Treatment of Bone Marrow Aplasia in Fanconi Anemia

Start date: July 2004
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety of the drug oxandrolone (a type of androgen steroid) in patients with Fanconi anemia (FA), and to determine if this drug can help in the treatment of bone marrow failure in these patients. Androgen steroids are male hormones that can stimulate the production of red blood cells (the cells which carry oxygen in the blood) and platelets (cells that help blood clot).

NCT ID: NCT00240734 Terminated - Anemia Clinical Trials

Treatment of Anemia in Diabetic Subjects With CKD

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

The purpose of this study is to compare the proportion of subjects receiving either Epoetin alfa (PROCRIT®) or placebo who are able to achieve a hemoglobin response, defined by at least a 1 gram/deciliter increase from baseline by Week 17.

NCT ID: NCT00239642 Completed - Anemia Clinical Trials

Safety and Efficacy of Iron Sucrose in Children

Start date: July 2005
Phase: Phase 4
Study type: Interventional

Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney disease (CKD) patients

NCT ID: NCT00239616 Completed - Anemia Clinical Trials

Pharmacokinetic Study of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin

Start date: June 2002
Phase: Phase 4
Study type: Interventional

This is an open-label, multicenter pharmacokinetic study of HD od PD patients receiving erythropoietin. Patients were administered 100mg of iron sucrose undiluted by slow IV push over 5 minutes. Patients underwent serial blood draws and were subsequently followed for 7 days for safety endpoints.

NCT ID: NCT00239239 Completed - Cancer Clinical Trials

Fractionated Dosing Study: Study to Evaluate Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies

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

The purpose of this study is to characterize the pharmacokinetics/pharmacodynamics (PK/PD) of darbepoetin alfa administered at a subcutaneous (SC) dose of 0.45 mcg/kg three times weekly (TIW) in anemic patients with non-myeloid malignancies receiving multicycle chemotherapy.

NCT ID: NCT00238043 Active, not recruiting - Clinical trials for Chronic Kidney Disease

Cohort Study to Determine the Long-Term Safety and Efficacy of Biogeneric Epoetin Treatment for Renal Anemia

Start date: August 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to establish the long-term safety and efficacy of Biogeneric Epoetin, the attainability of therapeutic target for anaemia management, and the impact of Epoetin treatment on long-term health outcome and its cost effectiveness.

NCT ID: NCT00236977 Completed - Anemia Clinical Trials

Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

Start date: August 2003
Phase: Phase 3
Study type: Interventional

To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.

NCT ID: NCT00236964 Completed - Anemia Clinical Trials

Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis

Start date: February 2001
Phase: Phase 3
Study type: Interventional

The purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with chronic renal failure who are not receiving dialysis.

NCT ID: NCT00236951 Completed - Anemia Clinical Trials

Intravenous (IV) Iron vs. No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy

Start date: February 2003
Phase: Phase 3
Study type: Interventional

To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone.