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

NCT02570854 | Completed Phase 1 FDA Drug

• 2 other identifiers: CCSJ137X22012017-002926-19
• Study Type: interventional
• Target: 40
• Locations: 4 countries
• Sites: 13

Brief Summary

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.

Conditions

Anemia, Iron-Deficiency

Keywords

Anemia

Outcome Measures

Primary Outcomes (2)

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

  safety and tolerability following administration of CSJ137

  baseline through 115 days after CSJ137 is administered

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

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

  Hemoglobin response at 28 days post-dose

Secondary Outcomes (2)

• Peak concentration (Cmax) of CSJ137 in serum

  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

• Area under the serum concentration versus time curve (AUC)

  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

Study Arms (2)

CSJ137

EXPERIMENTAL

In Part 1 up to 48 subjects will receive a single dose of CSJ137. In Part 2, up to 40 patients will be randomized to one of 2 arms with equal allocation: one CSJ137 dose arm from Part 1 and a placebo arm. Each patient in Part 2 will receive up to 2 doses (repeat dose).

Biological: CSJ137

Placebo

PLACEBO COMPARATOR

In Part 2, up to 40 patients will be randomized to one of 2 arms with equal allocation: one CSJ137 dose arm from Part 1 and a placebo arm. Each patient in Part 2 will receive up to 2 doses (repeat dose).

Drug: Placebo

Interventions

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.

CSJ137

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (13)

Novartis Investigative Site

San Diego, California, 91942, United States

Location

Novartis Investigative Site

Lakewood, Colorado, 80228, United States

Location

Novartis Investigative Site

Orlando, Florida, 32809, United States

Location

Novartis Investigative Site

Minneapolis, Minnesota, 55404, United States

Location

Novartis Investigative Site

Chattanooga, Tennessee, 37404, United States

Location

Novartis Investigative Site

Prague, 12808, Czechia

Location

Novartis Investigative Site

Ashkelon, 78278, Israel

Location

Novartis Investigative Site

Hadera, 38100, Israel

Location

Novartis Investigative Site

Jerusalem, 91120, Israel

Location

Novartis Investigative Site

Petah Tikva, 49100, Israel

Location

Novartis Investigative Site

Ramat Gan, Israel

Location

Novartis Investigative Site

Tel Aviv, 62439, Israel

Location

Novartis Investigative Site

London, SW17 0QT, United Kingdom

Location

Related Links

• Results for CCSJ137X2201 from the Novartis Clinical Trials Website
• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 7, 2015
• Study Start: September 22, 2015
• Primary Completion: May 13, 2020
• Study Completion: May 13, 2020
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

US (5); CZ (1); GB (1); IL (6)