Completed

ATNCSP #530 - Intensive vs. Conventional Renal Support in Acute Renal Failure

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

renal replacement therapy

Procedure
Who is being recruted

Urogenital Diseases+5

+ Female Urogenital Diseases and Pregnancy Complications

+ Kidney Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: October 2003
See protocol details

Summary

Principal SponsorUS Department of Veterans Affairs
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2003

Actual date on which the first participant was enrolled.

Primary Hypothesis: An intensive management strategy for renal support in critically ill patients with acute renal failure decreases mortality as compared to less intensive (conventionally recommended) management strategies for renal replacement therapy. Secondary Hypotheses: An intensive management strategy for renal support in critically ill patients with acute renal failure will shorten the duration of ARF, decrease the incidence and duration of non-renal complications and is cost-effective as compared to less intensive (conventionally recommended) management strategies for renal replacement therapy. Primary Outcomes: 60-day all-cause mortality. Secondary Outcomes: All-cause hospital mortality; 1-year all cause mortality; recovery of renal function; duration of renal support (dialysis-free days); ICU and hospital length of stay (ICU-and hospital-free days); non-renal organ system failures (organ-failure-free days); and discharge to "home" not on dialysis. Study Abstract: The optimal management of renal replacement therapy (RRT) in acute renal failure (ARF) is uncertain. The VA/NIH Acute Renal Failure Trial Network (ATN Study) is designed to test the hypothesis that a strategy of intensive renal support will decrease mortality in critically ill patients with ARF as compared to less intensive (conventionally recommended) management. In this multicenter, prospective trial, patients with ARF due to acute tubular necrosis will be randomized equally to intensive or conventional management strategies for RRT. In both arms, RRT will be initiated using the same criteria. Hemodynamically stable patients (SOFA cardiovascular score: 0-2) will receive intermittent hemodialysis (IHD) while hemodynamically unstable patients (SOFA cardiovascular score: 3-4) will be treated with continuous venovenous hemodiafiltration (CVVHDF) or sustained low-efficiency hemodialysis (SLED). Patients will convert between modalities of therapy as hemodynamic status changes over time. The intensity of therapy in IHD and SLED will vary between groups based on treatment frequency; with treatments provided 6-times per week in the intensive management strategy arm and 3-times per week in the conventional management strategy arm. In CVVHDF, intensity of therapy will vary based on effluent flow rate with a prescribed flow rate of 35 mL/kg/hour in the intensive management strategy arm and 20 mL/kg/hour in the conventional management strategy arm. Protocol therapy will be continued until renal function recovers or until day 28. The primary study end-point will be 60-day all-cause mortality. Other end-points will include hospital and 1-year mortality, recovery of renal function, duration of renal support, ICU and hospital length of stay, hospital discharge off of dialysis and development/recovery of non-renal organ failure. An economic analysis will be performed to assess the costs and relative cost effectiveness of the two strategies. The planned total enrollment of 1164 patients at 27 institutions over 44 months was selected to provide a power of 0.90 to detect a reduction in mortality from 55% to 45% with alpha=0.05 assuming a dropout/loss-to-follow-up rate of 10%. Study enrollment began in November 2003 and closed after 44 months on July 2, 2007. Total enrollment was 1124 subjects. Fewer than 3% of subjects withdrew from protocol therapy. Follow-up for the primary study endpoint (60-day all-cause mortality) concluded on August 31, 2007; one-year follow-up will conclude in July 2008. A type of dialysis solution used in the study was under IND with No. 67,631 and granted by Center for Drug Evaluation and Research in FDA.

Official TitleCSP #530 - Intensive vs. Conventional Renal Support in Acute Renal Failure 
Principal SponsorUS Department of Veterans Affairs
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1124 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesUrologic DiseasesRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesAcute Kidney Injury

Criteria

Inclusion Criteria: * Acute renal failure clinically consistent with a diagnosis of acute tubular necrosis * Plan for renal replacement therapy by clinical team * Receiving care in a critical care unit * One non-renal organ failure or sepsis * Age 18 or older * Patient or surrogate provides informed consent Exclusion Criteria: * Baseline serum creatinine \> 2 mg/dL (177 mol/L) in males, \> 1.5 mg/dL (133 mol/L) in females * Acute renal failure clinically believed to be due to an etiology other than acute tubular necrosis * More than 72 hours since meeting both of the following conditions: 1. Fulfillment of the definition of ARF; and 2. BUN \> 100 mg/dL (36 mmol/L) * More than 1 hemodialysis treatment or more than 24 hours since starting continuous renal replacement therapy * Prior kidney transplant * Pregnancy * Prisoner * Weight \> 128.5 kg * Non-candidacy for renal replacement therapy * Moribund state * Patient not expected to survive 28 days because of underlying terminal chronic medical condition * Comfort-measures-only status * Participation in a concurrent interventional study * Patient/surrogate refusal * Physician refusal

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.

Group II

Active Comparator
In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 22 locations

Suspended

Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock

No. Little Rock, United StatesSee the location
Suspended

VA Medical Center, San Francisco

San Francisco, United States
Suspended

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, United States
Suspended

VA Eastern Colorado Health Care System, Denver

Denver, United States
Completed22 Study Centers