A Clinical Trial of IntensiVE Dialysis (ACTIVE)
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| ClinicalTrials.gov Identifier: NCT00649298 |
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Recruitment Status :
Completed
First Posted : April 1, 2008
Last Update Posted : December 3, 2019
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| Condition or disease | Intervention/treatment | Phase |
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| Renal Replacement Therapy Renal Dialysis End Stage Kidney Disease End Stage Renal Disease Uremia | Procedure: haemodialysis | Phase 4 |
A rapidly increasing volume of observational data suggests substantial benefits may be associated with an increased duration of dialysis. As well as improved quality of life, improved functioning and beneficial changes in a variety of laboratory parameters, it has been suggested that extended dialysis sessions might reduce mortality and major morbidity. Uncontrolled data from centres that have been providing extended dialysis shows dramatically lower mortality rates compared to those observed in centres providing standard duration dialysis. Recent analyses of extended dialysis conclude that the savings achieved in drug and hospitalization costs may lead to an overall reduction in costs compared with traditional forms of dialysis.
In this trial, we propose to examine the effects of extended dialysis (24 hours weekly or more) compared to standard dialysis (18 hours or less weekly) in patients with ESKD. The proposed study is a multi-centre, open label, randomised, controlled trial.
The study began with a pilot phase which was converted to the current main study on the receipt of peer-reviewed funding for the full study.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | ACTIVE Dialysis - A Multicentre, Unblinded, Randomised, Controlled Trial to Assess Quality of Life, Clinical Outcomes and Cost Utility for Extended vs Standard Duration of Dialysis in Patients With End Stage Kidney Disease. |
| Study Start Date : | May 2008 |
| Actual Primary Completion Date : | July 2014 |
| Actual Study Completion Date : | October 2014 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: extended hours
24 or more hours per week of hemodialysis
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Procedure: haemodialysis
Comparison of different weekly duration of haemodialysis treatment
Other Names:
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Active Comparator: standard hours
18 or less hours per week of hemodialysis
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Procedure: haemodialysis
Comparison of different weekly duration of haemodialysis treatment
Other Names:
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- The primary end-point for this study is the difference in the change in quality of life between the two groups from randomisation to the 12 month follow-up as measured by the EQ-5D instrument. [ Time Frame: 12 months from randomisation ]
- Survival and cardiovascular analyses [ Time Frame: 12 months ]
- Quality of life and patient acceptability [ Time Frame: 12 months ]
- Safety outcomes [ Time Frame: 12 months ]
- Costs associated with each intervention [ Time Frame: 12 months ]
- Changes in biochemical and haematological parameters [ Time Frame: 12 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Incident or prevalent patients requiring maintenance haemodialysis therapy for ESKD
- Aged 18 years or older
- Undergoing dialysis for 18 hours per week or less
- Suitable for either extended or standard dialysis in the view of the treating physician
- Agreeable to randomisation
Exclusion Criteria:
- Life expectancy of less than 6 months
- Definite plans to undergo renal transplantation within 12 months of entry to the study
- Inability to complete quality of life questionnaire
- Concomitant major illness that would limit assessments and followup
- High chance that the patient will not adhere to study treatment and follow up in the view of the treating physician.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00649298
Show 40 study locations
| Principal Investigator: | Vlado Perkovic, MBBS PhD | The George Institute |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | The George Institute |
| ClinicalTrials.gov Identifier: | NCT00649298 |
| Other Study ID Numbers: |
GI-R-A001- 09 |
| First Posted: | April 1, 2008 Key Record Dates |
| Last Update Posted: | December 3, 2019 |
| Last Verified: | December 2019 |
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Randomized Controlled Trial Clinical Trial Controlled Clinical Trial Clinical Trial, Phase IV Multicenter Study End Stage Kidney Disease Hemodialysis Renal Dialysis Renal Replacement Therapy Nocturnal Dialysis Extended dialysis Quality of Life Quality Adjusted Life Year Hypertrophy, Left Ventricular Blood Pressure |
Hypertension Anemia Hematinics Erythropoiesis Stimulating Agents Cost-utility Analysis Economic Evaluation Health Care Utilisation Health Care Costs Health Expenditures Hospitalization Cost Analysis Cardiovascular Diseases Acute Coronary Syndrome Myocardial Infarction Stroke |
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Kidney Diseases Kidney Failure, Chronic Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |
Male Urogenital Diseases Renal Insufficiency, Chronic Renal Insufficiency Chronic Disease Disease Attributes Pathologic Processes |