Autopsy report · NCT00663455

Randomized Study to Reduce Calcineurininhibitor Toxicity in Pediatric and Adolescent Kidney Transplant Recipients

“Recruitment goals were not achieved. Extension of the trial concept had to be abjected due to methodological reasons.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 8 months before it started.
• Ran for about 4 years 6 months before it stopped.
• 50 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 4

Sponsor

University of Erlangen-Nürnberg Medical School

Sponsor type

University, hospital or other

Conditions

Kidney Transplant

Interventions

Reduction of cyclosporine A (CSA)-dosing

Participants

50

Sites

10

Countries

Germany

Trials that died the same way

• Comprehensive Optimization At-time of Radical Cystectomy Intervention
  “Recruitment efforts had begun; however, no participants were enrolled, and the trial had been on a prolonged hold.” (71% match in meaning)
• Comparing Satisfaction With a Participatory Driven Web-application and a Standard Website
  “The primary trial was stopped. Since, a feasibility study showed that recruitment was not feasible. We obtain a recruitment rate of 15 %.” (70% match in meaning)
• ImmunoNutrition and Colorectal Adenocarcinoma Surgery - INCAS Study
  “problems encountered during the patient recruitment phase which led to the pre-established recruitment objectives not being met.” (69% match in meaning)
• Pleural Suction Additional to Thoracostomy Tube for Traumatic Hemothorax
  “It was not possible to achieve adequate recruitment to complete the necessary sample. The rate at which patients are recruited does not allow for continued participation” (67% match in meaning)
• Assessment of Flow With the New Four-dimensional Velocity-encoded Magnetic Resonance Imaging Technique
  “Logistically recruitment was not applicable after trial of a few patients” (67% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.