Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000145000
Ethics application status
Approved
Date submitted
9/02/2010
Date registered
12/02/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Red Cell Life Span (RBC) in Chronic Kidney Disease (CKD)
Scientific title
Red Blood Cell (RBC) Survival in Patients with Chronic Kidney Disease (CKD) and on Dialysis
Secondary ID [1] 1399 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 256786 0
Red blood cell life span 256787 0
Condition category
Condition code
Renal and Urogenital 256933 256933 0 0
Kidney disease
Blood 256934 256934 0 0
Anaemia

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is designed to investigate red blood cell survival in patients with moderate CKD, on haemodialysis and on peritoneal dialysis in comparison with controls. RBC survival will be measured by means of labelling with radioactive chromium, whereby a sample of RBCs of a cross-section of ages is tagged and the disappearance of radioactivity is followed over a period of 4 weeks time.
Intervention code [1] 255991 0
Not applicable
Comparator / control treatment
Red blood cell survival in patients with CKD will be compared with the red blood cell survival of healthy controls.
Control group
Active

Outcomes
Primary outcome [1] 257814 0
red blood cell survival in patients with moderate CKD, on haemodialysis and on peritoneal dialysis in comparison with controls. Red blood cell life span will be measured by labelling a sample of RBCs with radioactive chromium and then disappearance of radioactivity is followed over time.
Timepoint [1] 257814 0
The baseline (equivalent to 100% of systemically administered radioactivity) sample (10ml) will be collected after 10-30 minutes. Subsequent samples will be collected every 3-4 days till day 24 and the final sample will be collected on day 32.
Secondary outcome [1] 263230 0
Nil
Timepoint [1] 263230 0
Nil

Eligibility
Key inclusion criteria
Patients of at least 18 years of age and on dialysis at least for 2 months haemodialysis (HD) and peritoneal dialysis (PD) will be invited to participate in this study, stable subjects with moderate CKD (stage III, defined as a glomerular filtration rate (GFR) (30-59 ml/min), subjects with diabetes mellitus with normal renal function and healthy controls
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
HD and PD patients not on erythropoietin and/or iron supplement therapy. Haemoglobin concentrations not within the recommended target range (Hb: 110-130 g/l). Evidence of recent blood loss and or recent blood transfusion. Intercurrent inflammatory illness or drugs which may influence bone marrow function. Solid organ maligancy. Unstable glycaemic control. Pregnancy. Women of child bearing potential will be advised to practise ab acceptable form of contraception for the duration of the study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment outside Australia
Country [1] 2473 0
New Zealand
State/province [1] 2473 0

Funding & Sponsors
Funding source category [1] 256497 0
University
Name [1] 256497 0
Otago Medical Research Foundation
Country [1] 256497 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Great King Street PO Box 913 Dunedin 9010
Country
New Zealand
Secondary sponsor category [1] 255808 0
Hospital
Name [1] 255808 0
Dunedin Hospital
Address [1] 255808 0
Great King Street Private Bag Dunedin 9010
Country [1] 255808 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258544 0
Lower South Regional Ethics Committee
Ethics committee address [1] 258544 0
PO Box 5849 Dunedin 9010
Ethics committee country [1] 258544 0
New Zealand
Date submitted for ethics approval [1] 258544 0
Approval date [1] 258544 0
07/09/2009
Ethics approval number [1] 258544 0

Summary
Brief summary
Anaemia associated with chronic kidney disease (CKD) is believed to be caused by erythropoietin deficiency and decreased red blood cell (RBC) survival. The toxic uremic environment and mechanical damage caused by dialysis is thought to account for the reduced red cell life span. However the clinical evidence for this is minimal. To date no accurate data on RBC survival in CKD is available. We propose to undertake a study to investigate red blood cell survival in patients with moderate CKD, on haemodialysis and on peritoneal dialysis in comparison with controls. RBC survival will be measured by means of labelling with radioactive chromium. As almost half the patients with CKD are diabetic, glycaemic control remains an important aspect of their management. Therefore RBC survival will influence the accuracy of markers of glycaemic control, like HbA1c.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30820 0
Address 30820 0
Country 30820 0
Phone 30820 0
Fax 30820 0
Email 30820 0
Contact person for public queries
Name 14067 0
Dr Frederiek Vos
Address 14067 0
Medical & Surgical Sciences
Dunedin School of Medicine
University of Otago
PO Box 913 Dunedin 9010
Country 14067 0
New Zealand
Phone 14067 0
+64 3 4740999
Fax 14067 0
+64 3 4747641
Email 14067 0
[email protected]
Contact person for scientific queries
Name 4995 0
Dr Frederiek Vos
Address 4995 0
Medical & Surgical Sciences
Dunedin School of Medicine
University of Otago
PO Box 913 Dunedin 9010
Country 4995 0
New Zealand
Phone 4995 0
+64 3 4740999
Fax 4995 0
+64 3 4747641
Email 4995 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.