A two-part Single- and repeat-dose Study of CSJ137 in Anemic Chronic Hemodialysis Patients

Phase 1

• Conditions: Functional iron deficiency anemia; MedDRA version: 20.0Level: LLTClassification code 10002272Term: AnemiaSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-002926-19-GB
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-13
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1.Hemodialysis-dependent for at least 2 months prior to screening.
2.Receiving hemodialysis at least 2 times per week
3.Receiving erythropoietin (EPO) therapy.
4.Hemoglobin (Hgb) = 8.5 and < 11.5 g/dL at screening.
5.Ferritin >500 ng/mL and = 2000 ng/mL at screening.
6.TSAT = 50% at a minimum of one time point during the 90 days prior to baselineOther protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 78
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Known diagnosis of hemochromatosis, bone marrow malignancy, lymphatic malignancy or myelodysplastic syndrome.
2.History of dialysis AV fistula thrombosis within 2 months prior to screening, or 2 or more episodes of AV fistula thrombosis within 6 months prior to screening.
3.Liver disease/dysfunction (Child-Pugh score = 6), prior liver transplant, heart failure (NYHA Class III or IV); gastrointestinal bleeding.
4.A positive Hepatitis B surface antigen test result. Patients with Hepatitis C Virus (HCV) infection may be included if all other liver function eligibility criteria are met.
5.ALT, AST or bilirubin = 1.5x ULN within 4 weeks prior to baseline.
6.Uncontrolled renal osteodystrophy defined as the coexistence of all of the following at screening (1) intact PTH = 750 pg/mL, (2) serum phosphate above the upper limit of the lab normal range, and (3) calcium x phosphate product > 75 mg2/dL2 (6.05 mmol2/L2).
7.Conditions predisposing to an increased risk of serious infection, such as an indwelling vascular catheter (central venous line or non tunneled/acute hemodialysis catheter) or active infection requiring antibiotic therapy at any time during the 2 weeks prior to screening. Tunneled hemodialysis catheters, and other permanent catheters are permitted.
8.Blood transfusion administered within 4 weeks prior to baseline.
9.Cancer patients who are actively undergoing chemotherapy at screening or who have received chemotherapy within 3 months prior to screening.
Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified