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NCT02217410 · ClinicalTrials.gov registry record · Phase 1

CCFZ533X2201 - PoC Study in de Novo Renal Transplantation

A Phase 1 study of Kidney Transplantation, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
59
Enrollment target
14
Study locations

NCT02217410 is a Phase 1 study of Kidney Transplantation that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 59 participants, below the 266-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (78% lower). The trial reports 14 study locations across 8 states.

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The verdict

NCT02217410, a Phase 1 study of Kidney Transplantation, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
59 participants
Enrollment target
14
Study locations

Study Summary

The purpose of this study was to investigate the safety, tolerability, pharmacokinetics (PK) and potential for CFZ533 to replace calcineurin inhibitors (CNI), while providing a similar rate of acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors.

Conditions Studied

Kidney Transplantation

Interventions

  • DRUG Tacrolimus (Tac)
  • DRUG Mycophenolate mofetil (MMF)
  • BIOLOGICAL CFZ533
  • DRUG Corticosteroids (CS)
  • BIOLOGICAL anti-IL2 Induction

Study Locations (14)

Other

  • Novartis Investigative Site - Berlin
  • Novartis Investigative Site - Essen
  • Novartis Investigative Site - Hamburg
  • Novartis Investigative Site - Heidelberg
  • Novartis Investigative Site - Groningen
  • Novartis Investigative Site - Rotterdam

Michigan

  • Novartis Investigative Site - Ann Arbor
  • Novartis Investigative Site - Detroit

Colorado

  • Novartis Investigative Site - Aurora

Maryland

  • Novartis Investigative Site - Baltimore

New Jersey

  • Novartis Investigative Site - Livingston

Ohio

  • Novartis Investigative Site - Cincinnati

São Paulo

  • Novartis Investigative Site - São Paulo

The Netherlands

  • Novartis Investigative Site - Utrecht

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2015-02-05
Est. Completion 2017-11-29
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02217410

The ClinicalTrials.gov registry entry for NCT02217410 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 266-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (78% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Kidney Transplantation appearing as the primary indexed condition, and to 5 interventions - of which Tacrolimus (Tac) is the first listed.

NCT02217410 reports 14 study locations spanning 8 distinct geographic areas - top geographies include Other, Michigan, Colorado.

Frequently Asked Questions

What is clinical trial NCT02217410 about?

NCT02217410 is a clinical study titled "CCFZ533X2201 - PoC Study in de Novo Renal Transplantation". The purpose of this study was to investigate the safety, tolerability, pharmacokinetics (PK) and potential for CFZ533 to replace calcineurin inhibitors (CNI), while providing a similar rate of acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allogr...

What is the current status of trial NCT02217410?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2015-02-05. Estimated completion is 2017-11-29.

What conditions does trial NCT02217410 study?

This clinical trial studies the following conditions: Kidney Transplantation.

What interventions are being tested in trial NCT02217410?

The interventions under investigation include: Tacrolimus (Tac) (DRUG), Mycophenolate mofetil (MMF) (DRUG), CFZ533 (BIOLOGICAL), Corticosteroids (CS) (DRUG), anti-IL2 Induction (BIOLOGICAL).

Who is sponsoring clinical trial NCT02217410?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02217410 being conducted?

This trial has 14 study locations across Colorado, Maryland, Michigan, New Jersey, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.