The Effect of Pre-treatment Biopsy for Non-neoplastic Renal Disease vs no Biopsy on Estimated Glomerular Filtration Rate in Patients With Small Renal Mass: a Single-center, Single-blinded, Randomized, Parallel Group Clinical Trial

Not Applicable

Withdrawn

• Conditions: Kidney Neoplasms
• Interventions: Procedure: Additional biopsy

• Registration Number: NCT02841020
• Lead Sponsor: University of Virginia

Brief Summary

The purpose of this study is to determine if biopsy for non-neoplastic renal disease for patients with a small renal mass results in greater postoperative renal function than the current standard of care (no additional biopsy).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-19
• Study First Posted: 2016-07-21
• Status Verified: 2017-11
• Study Start: 2018-06
• Last Update Submitted: 2018-10-26
• Last Update Posted: 2018-10-30
• Primary Completion: 2019-12
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age 18 or greater
• Scheduled for renal biopsy as part of clinical care
• Diagnosis of small renal mass (< 4cm) based on imaging (CT, MRI, Ultrasound, or other)
• Patient must provide written, informed consent for study procedures before randomization
• Renal mass must be primarily solid (as opposed to cystic) in nature

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Exclusion Criteria

• Patients less than 18 years of age
• Patients who are prisoners
• Women who are pregnant-self reported
• Patients with Bosniak 3 or 4 cystic renal masses
• Patients with history of renal transplantation
• Patients with eGFR less than 30-based on review of clinical labs
• Patients on dialysis
• Patients with bleeding disorders

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental additional biopsy	Additional biopsy	Additional biopsy

Primary Outcome Measures

Name	Time	Method
difference in change in glomerular filtration rate (GFR)	6 months