Trial · NCT00087022

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

NCT00087022, Phase 3, Completed, Heidelberg Pharma AG; results first posted 2018-09-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer. Trials, record NCT00087022. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00087022

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer
NCT number: NCT00087022
Status: Completed
Phases: Phase 3
Enrollment: 864 participants, actual
Lead sponsor: Heidelberg Pharma AG
Conditions: Kidney Cancer
Interventions: girentuximab, placebo
First posted: 2004-07-12
Last updated: 2018-11-27
Results first posted: 2018-09-12

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Disease-free Survival	Until signs of recurrence or until 360 local DFS events have occurred (median follow-up of 4.5 years)	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.
Primary	Overall Survival	After 419 OS events or 60 months after the last patient has been enrolled, whichever is the later (median follow-up of 4.5 years)	Overall Survival (OS) calculated from the date of randomization to the date of death. Patients with no documented death will be censored at the date of their last study evaluation.
Secondary	Quality of Life - Global Health Status	At 12 months	Quality of life by EORTC Quality of Life Questionnaire-C30 - Global Health Status at 12 months. A high score for the global health status/QoL represents a high QoL with 0 being the minimum and 100 being the maximum.
Secondary	Pharmacokinetics of WX-G250	Week 8	Quantitative determination of cG250 (Girentuximab) trough serum profiles at week 8 (steady state concentration).

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease-free Survival	Until signs of recurrence or until 360 local DFS events have occurred (median follow-up of 4.5 years)	All patients that were enrolled were included in the ITT population used for efficacy analysis	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Overall Survival	After 419 OS events or 60 months after the last patient has been enrolled, whichever is the later (median follow-up of 4.5 years)	All patients that were enrolled were included in the ITT population used for efficacy analysis	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Quality of Life - Global Health Status	At 12 months	Patients still on study who completed the questionnaire	score on a scale	MEAN
SECONDARY	Pharmacokinetics of WX-G250	Week 8	Patients who did sign amendment #3 to the study protocol and received their cG250 infusion as scheduled in the study protocol	µg/mL	MEAN
POST_HOC	Disease Free Survival (DFS) for Patients With CAIX Score >= 2.6	Until signs of recurrence or until 360 local DFS events have occurred (median follow-up of 4.5 years)	This analysis includes patients having a CAIX Expression equal or above the CAIX score of 2.6.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Disease-free Survival	Intervention	192		Participants
Disease-free Survival	Placebo	197		Participants
Overall Survival	Intervention	91		Participants
Overall Survival	Placebo	90		Participants
Quality of Life - Global Health Status	Intervention	71	Standard Deviation 21	score on a scale
Quality of Life - Global Health Status	Placebo	71	Standard Deviation 20	score on a scale
Pharmacokinetics of WX-G250	Intervention	8.7	Standard Deviation 5.8	µg/mL
Disease Free Survival (DFS) for Patients With CAIX Score >= 2.6	Intervention	20		Participants
Disease Free Survival (DFS) for Patients With CAIX Score >= 2.6	Placebo	39		Participants

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Intervention	433
Overall Study	STARTED	Placebo	431
Overall Study	Treated (Safety Population)	Intervention	431
Overall Study	Treated (Safety Population)	Placebo	424
Overall Study	COMPLETED	Intervention	379
Overall Study	COMPLETED	Placebo	376
Overall Study	NOT COMPLETED	Intervention	54
Overall Study	NOT COMPLETED	Placebo	55

Source ClinicalTrials.gov

Adverse events154

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	DIARRHOEA	Gastrointestinal disorders	Intervention	27	431
other	DIARRHOEA	Gastrointestinal disorders	Placebo	39	424
other	NAUSEA	Gastrointestinal disorders	Intervention	35	431
other	NAUSEA	Gastrointestinal disorders	Placebo	29	424
other	VOMITING	Gastrointestinal disorders	Intervention	28	431
other	VOMITING	Gastrointestinal disorders	Placebo	18	424
other	BACK PAIN	Musculoskeletal and connective tissue disorders	Intervention	34	431
other	BACK PAIN	Musculoskeletal and connective tissue disorders	Placebo	37	424
other	ARTHRALGIA	Musculoskeletal and connective tissue disorders	Intervention	27	431
other	ARTHRALGIA	Musculoskeletal and connective tissue disorders	Placebo	22	424

1 to 10 of 154Source ClinicalTrials.gov

See all 154 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intervention
Total, all-cause mortality	Placebo
Total, other adverse events	Intervention	164	431
Total, other adverse events	Placebo	166	424
Total, serious adverse events	Intervention	36	431
Total, serious adverse events	Placebo	36	424

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27418270	DERIVED	PubMed
27787547	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Intervention vs Placebo: Disease-free Survival	Trial comparisons
Intervention vs Placebo: Disease Free Survival (DFS) for Patients With CAIX Score >= 2.6	Trial comparisons
Intervention vs Placebo: Overall Survival	Trial comparisons
Intervention vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00087022

GET https://conductscience.org/api/trials/v1/NCT00087022/events?page=2

API reference For AI assistants