Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01279538 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess Pharmacokinetic, Pharmacodynamic, Safety and Tolerability of ASKP1240 in de Novo Kidney Transplantation

A Phase 1 study, sponsored by Astellas Pharma.

Completed
Registry status
Phase 1
Development phase
50
Enrollment target

NCT01279538: Completed Phase 1 study, sponsored by Astellas Pharma.

NCT01279538 is a Phase 1 study that has completed, run by Astellas Pharma. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01279538, a Phase 1 study, has completed, sponsored by Astellas Pharma.

COMPLETED
Registry status
Phase 1
Development phase
50 participants
Enrollment target

Study Summary

The purpose of the study is to assess the Pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of ASKP1240 when administered to subjects who received a de novo kidney transplant.

Interventions

  • DRUG Placebo
  • DRUG bleselumab

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2010-11-17
Est. Completion 2012-01-23
Phase Phase 1
Astellas Pharma

165 total trials

What the finished NCT01279538 record still lists

NCT01279538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01279538 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01279538 about?

NCT01279538 is a clinical study titled "A Study to Assess Pharmacokinetic, Pharmacodynamic, Safety and Tolerability of ASKP1240 in de Novo Kidney Transplantation". The purpose of the study is to assess the Pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of ASKP1240 when administered to subjects who received a de novo kidney transplant.

What is the current status of trial NCT01279538?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2010-11-17. Estimated completion is 2012-01-23.

What interventions are being tested in trial NCT01279538?

The interventions under investigation include: Placebo (DRUG), bleselumab (DRUG).

Who is sponsoring clinical trial NCT01279538?

This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01279538's enrollment target sits among peer trials

50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00200889 · 50 participants · Early Phase 1

    Mapping Auricular Vagus Nerve Circuitry

  • NCT00409435 · 50 participants · Phase 2

    A Study of Pyridostigmine in Postural Tachycardia Syndrome

  • NCT01202305 · 50 participants

    The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

  • NCT01225913 · 50 participants · Phase 4

    Mechanism(s) of Airflow Limitation During Exacerbation of Asthma

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT01279538, the US trial registry maintained by the National Library of Medicine. NCT01279538 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.