CTRI/2011/11/002153
Completed
Phase 1
A phase I/II, open label, single escalating dose study to assess safety, pharmacodynamics, pharmacokinetics and immunogenicity of polysialylated erythropoietin administered intravenously in chronic kidney disease patients who are on haemodialysis.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Patients with chronic kidney disease who are on haemodialysis
- Sponsor
- Serum Institute of India Pvt Ltd
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subjects willing to give voluntary written informed consent.
- •2\.Males \>\= 18 and \<\= 70 years of age and post\-menopausal Females \<\= 70 years of age.
- •3\.Clinically stable on hemodialysis for \>\= 3 months before screening (3 sessions per week).
- •4\.Subjects with adequate dialysis ( as determined by Kt/V\>\=1\.2 or URR\>\=65%) before enrollment.
- •5\.Hemoglobin value of \>\=8g/dL and \<\= 11 g/dL within 14 days prior to administration of study drug
- •6\.Serum ferritin level \>\= 200 µg/L and transferrin saturation \>\= 20% within 14 days prior to administration of study drug
- •7\.RBC folate level and Vitamin B12 level above the lower limit of normal within 14 days prior to administration of study drug.
Exclusion Criteria
- •1\.Has received erythropoiesis stimulating agent in the last 6 weeks.
- •2\.Blood transfusions within 4 weeks before screening or during the screening period or anticipated blood transfusion within one month after start of the study.
- •3\.Nonrenal causes of anemia (e.g., Hemoglobinopathy \[e.g., homozygous sickle cell disease, thalassemia of all types] , hemolysis, vitamin B12 or folic acid deficiency)
- •4\.History suggestive of pure red cell aplasia (PRCA)
- •5\.C Reactive Protein (CRP) greater than 15 mg/dL within 14 days prior to administration of study drug
- •6\.Secondary hyperparathyroidism as evaluated by serum parathormone (PTH) level greater than 800pg/ml at screening.
- •7\.Poorly controlled hypertension within 4 weeks prior to study drug administration, as per Investigators clinical judgment (e.g. systolic \>\= 170 mm Hg, diastolic \>\= 100 mm Hg on repeat readings)
- •8\. Known intolerance to parenteral iron supplementation
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 1
A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of EARLI-001 in subjects with lung cancerACTRN12620001178932Earli, Pty Ltd10
Terminated
Phase 1
A Phase I Open-Label, Single Dose, Dose Escalation Study of KB002, a Chimeric Monoclonal Antibody Which Binds to GM-CSF (Granulocyte Macrophage Colony Stimulating Factor), in Patients with Chronic Idiopathic Thrombocytopenia Purpura (ITP)Idiopathic Thrombocytopenia Purpura (ITP)Blood - Other blood disordersACTRN12606000459527KaloBios Pharmaceuticals Inc27
Active, not recruiting
Phase 1
An open-label, two-stage Phase I/IIa dose escalation study of BT062 in metastatic triple receptor-negative breast cancer and in metastatic transitional cell carcinoma of the urinary bladderSubjects with metastatic triple receptor-negative breast cancer (TNBC) who failed at least 2 and no more than 4 prior chemotherapies or alternativelySubjects with metastatic transitional cell carcinoma (TCC) of the urinary bladder who failed at least 1 and no more than 2 prior chemotherapies.MedDRA version: 19.0Level: PTClassification code 10071664Term: Bladder transitional cell carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2013-003252-20-DEBiotest AG180
Active, not recruiting
Phase 1
An open-label, two-stage Phase I/IIa dose escalation study of BT062 in metastatic triple receptor-negative breast cancer and in metastatic transitional cell carcinoma of the urinary bladderSubjects with metastatic triple receptor-negative breast cancer (TNBC) who failed at least 2 and no more than 4 prior chemotherapies or alternativelySubjects with metastatic transitional cell carcinoma (TCC) of the urinary bladder who failed at least 1 and no more than 2 prior chemotherapies.MedDRA version: 18.0Level: PTClassification code 10071664Term: Bladder transitional cell carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2013-003252-20-BEBiotest AG180
Active, not recruiting
Phase 1
Study to Assess the Pharmacokinetics, Safety, and Tolerability of Pimavanserin in Adolescents with Psychiatric DisordersPsychiatric DisordersMedDRA version: 20.0Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 20.0Level: HLTClassification code 10037177Term: Infancy, childhood and adolescence psychiatric disorders NECSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]EUCTR2018-001064-30-BGACADIA Pharmaceuticals Inc.36