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NCT00087022 · ClinicalTrials.gov registry record · Phase 3

Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer

A Phase 3 study, sponsored by Heidelberg Pharma.

Completed
Registry status
Phase 3
Development phase
864
Enrollment target

NCT00087022: Completed Phase 3 study, sponsored by Heidelberg Pharma.

NCT00087022 is a Phase 3 study that has completed, run by Heidelberg Pharma. The registered enrollment target is 864 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00087022, a Phase 3 study, has completed, sponsored by Heidelberg Pharma.

COMPLETED
Registry status
Phase 3
Development phase
864 participants
Enrollment target

Study Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether monoclonal antibody therapy is effective in treating kidney cancer. PURPOSE: This randomized phase III trial is studying monoclonal antibody therapy to see how well it works in treating patients who have undergone surgery for nonmetastatic primary kidney cancer.

Primary Outcome

Disease Free Survival (DFS) calculated from the date of randomization up to and including the date of documented relapse as confirmed by the CT, death or start of new anti-tumor therapy.

Interventions

  • OTHER placebo
  • BIOLOGICAL girentuximab

Trial Details

FieldValue
Enrollment Target 864 participants
Start Date 2004-07
Est. Completion 2012-10
Phase Phase 3
Heidelberg Pharma

5 total trials

What the finished NCT00087022 record still lists

NCT00087022 is an interventional study that assigns participants to a tested intervention. The registered 864 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% higher).

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

NCT00087022 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00087022 about?

NCT00087022 is a clinical study titled "Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer". RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether monoclonal antibody therapy is effective in treating kidney cancer. PURPOSE: This randomized phase III trial is studying...

What is the current status of trial NCT00087022?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 864 participants. The study started on 2004-07. Estimated completion is 2012-10.

What interventions are being tested in trial NCT00087022?

The interventions under investigation include: placebo (OTHER), girentuximab (BIOLOGICAL).

Who is sponsoring clinical trial NCT00087022?

This trial is sponsored by Heidelberg Pharma, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00087022's enrollment target sits among peer trials

864 378th of 2000 higher than 1,621 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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

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Source: ClinicalTrials.gov NCT00087022, the US trial registry maintained by the National Library of Medicine. NCT00087022 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.