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Completed

NCT Number: NCT02570854

A Two-part Single- and Repeat-dose Study of CSJ137 in Anemic Chronic Hemodialysis Patients

The study will assess the safety, tolerability and efficacy of CSJ137 in chronic hemodialysis patients. It is hypothesized that treatment with CSJ137 may improve the level of hemoglobin in patients on chronic hemodialysis with iron-restricted anemia while reducing the need for dosing with erythropoietin and intravenous iron in these patients.

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Key information

Conditions

Anemia, Iron-Deficiency Anemia Anemia, Hypochromic Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Prague, Czechia

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About this study

This posting discloses information about Part 1 of CCSJ137X2201. Another part, Part 2, of this trial was planned for conduct subsequent to the initiation of Part 1 and would have a different design than Part 1. However, due to internal strategic non-safety related decision, Part 2 is not going to be conducted and the trial will be terminated after Part 1.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hemodialysis-dependent for at least 2 months prior to screening.
  • Receiving hemodialysis at least 2 times per week
  • Receiving erythropoietin (EPO) therapy.
  • Hemoglobin (Hgb) ≥ 8.5 and < 11.5 g/dL at screening.
  • Ferritin >500 ng/mL and ≤ 2000 ng/mL at screening.
  • TSAT ≤ 50% at a minimum of one time point during the 90 days prior to baseline.

Exclusion criteria

  • Known diagnosis of hemochromatosis, bone marrow malignancy, lymphatic malignancy or myelodysplastic syndrome.
  • 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.
  • Liver disease/dysfunction (Child-Pugh score ≥ 6), prior liver transplant, heart failure (NYHA Class III or IV); gastrointestinal bleeding.
  • 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.
  • ALT, AST or bilirubin ≥ 1.5x ULN within 4 weeks prior to baseline.
  • Uncontrolled renal osteodystrophy
  • 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.
  • Blood transfusion administered within 4 weeks prior to baseline.
  • Patients who received CSJ137 dose in the past.

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

CSJ137

Biological

Starting dose is 0.010 mg/kg and dose escalation will proceed with semi-log increase steps to a maximum dose level 10 mg/kg. Subjects receive the treatment via up to 30 minutes intravenous infusion.

Placebo

Drug

Subjects will be dosed with a matching placebo (vehicle control) via up to 30 minutes intravenous infusion.

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: baseline through 115 days after CSJ137 is administered

    safety and tolerability following administration of CSJ137

  2. Minimum active dose of CSJ137 determined by assessment of levels of hemoglobin in blood, without evidence of liver dysfunction or other safety concerns.

    Time frame: Hemoglobin response at 28 days post-dose

    to determine the minimum dose of CSJ137 that is active for treatment

Secondary outcomes

  1. Peak concentration (Cmax) of CSJ137 in serum

    Time frame: before CSJ137 is administered, then 0.5 hours and 6 hours after CSJ137 is administered on Day 1. Also 1, 2, 3, 5, 12, 19, 28, and 84 days after CSJ137 is administered

    to assess the concentration of CSJ137 in the body over time

  2. Area under the serum concentration versus time curve (AUC)

    Time frame: before CSJ137 is administered, then 0.5 hours and 6 hours after CSJ137 is administered on Day 1. Also 1, 2, 3, 5, 12, 19, 28, and 84 days after CSJ137 is administered

    to assess the concentration of CSJ137 in the body over time

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A First-in-human, Two-part (Open Label, and Randomized/Double Blind/Placebo Controlled), Single- and Repeat-dose Study of CSJ137 in Erythropoietin-treated Chronic Hemodialysis Patients With Functional Iron-deficiency Anemia

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Oct 7, 2015
Registry last updated
Oct 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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