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

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ClinicalTrials.gov Identifier: NCT02570854
Recruitment Status : Recruiting
First Posted : October 7, 2015
Last Update Posted : July 31, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Anemia, Iron-Deficiency Biological: CSJ137 Drug: Placebo Phase 1 Phase 2

Detailed Description:
This posting discloses information about Part 1 of CCSJ137X2201. Another part, Part 2, of this trial is planned for conduct subsequent to the initiation of Part 1 and will have a different design than Part 1. The details of the design for this additional part are planned for disclosure in advance of conduct of Part 2.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 22, 2015
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Dialysis Iron

Arm Intervention/treatment
Experimental: CSJ137
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
Starting dose is 0.010 mg/kg and subsequent doses will determined using adaptive Bayesian logistc regression model (adaptive dose escalation strategy). Subjects receive the treatment over 30-60 minutes via intravenous infusion.

Placebo Comparator: Placebo
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
Subjects will be dosed with a matching placebo (vehicle control) over 30-60 minutes via intravenous infusion.




Primary Outcome Measures :
  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 transferrin saturation and hemoglobin in serum and blood, respectively [ Time Frame: Hemoglobin response at 28 days post-dose ]
    to determine the minimum dose of CSJ137 that is active for treatment


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ≤ 1000 ng/mL at screening.
  6. TSAT ≤ 50% at a minimum of one time point during the 90 days prior to baseline, and TSAT ≤ 50% at baseline.

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 asthe 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 hemodialysis catheter) or active infection requiring antibiotic therapy at any time during the 2 weeks prior to screening.
  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 inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570854


Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
United States, Colorado
Novartis Investigative Site Recruiting
Lakewood, Colorado, United States, 80228
United States, Florida
Novartis Investigative Site Recruiting
Orlando, Florida, United States, 32809
United States, Minnesota
Novartis Investigative Site Recruiting
Minneapolis, Minnesota, United States, 55404
United States, Tennessee
Novartis Investigative Site Recruiting
Chattanooga, Tennessee, United States, 3740
Israel
Novartis Investigative Site Recruiting
Ashkelon, Israel, 78278
Novartis Investigative Site Recruiting
Jerusalem, Israel
Novartis Investigative Site Recruiting
Petach Tikva, Israel, 49100
Sponsors and Collaborators
Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02570854     History of Changes
Other Study ID Numbers: CCSJ137X2201
2017‐002926‐19 ( EudraCT Number )
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Anemia

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases