Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001018808
Ethics application status
Approved
Date submitted
17/09/2012
Date registered
20/09/2012
Date last updated
21/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a new and more cost-effective treatment option for anaemia of chronic kidney disease.
Scientific title
A 6 month evaluation of pentoxifylline (Trental) treatment for anaemia of chronic kidney disease
Secondary ID [1] 281045 0
Nil
Universal Trial Number (UTN)
Trial acronym
Trental renal study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Anaemia 287181 0
Condition category
Condition code
Renal and Urogenital 287512 287512 0 0
Kidney disease
Blood 287513 287513 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Serial measurements of haematological parameters, serum Fe biochemistry, hepcidin, multiple pro-inflammatory cytokines (via multiplex cytokine array ELISA including IL6, IL1Beta, IFNBeta, TNF) and erythropoietin levels will be undertaken in our laboratories at Fremantle Hospital.
There will be a 1 month run-in period during which these parameters will be monitored at t=-4 weeks and t=0 weeks (When study medication will commence). Study medication will be Pentoxifylline (Trental) or matching placebo 400mg twice a day orally for 6 months.
Thereafter patients will be clinically reviewed every month with blood samples obtained monthly up to 6 months.
Intervention code [1] 285503 0
Treatment: Drugs
Comparator / control treatment
Forty-four anaemic CKD patients who are not on dialysis and who have not received Fe and ESA therapy will be randomized to receive treatment (n=22, PTF 400 mg twice a day) or placebo (n=22) for 6 months.The placebo will be identical to the pentoxifylline (Trental) in taste and appearance but without the active ingredient.
ESA will be initiated when haemoglobin falls below 100 g/L in the absence of Fe-deficiency; Fe therapy will be used when SEVERE Fe-deficiency develops (ferritin <100 microg/L and transferrin saturation <10%) using standard protocols.
Control group
Placebo

Outcomes
Primary outcome [1] 287759 0
Haemoglobin, measured by blood analysis.
Timepoint [1] 287759 0
Monthly within the 6 months
Primary outcome [2] 288030 0
The need to start erythropoiesis stimulating agent/iron therapy by end of study (yes/no and total dose of each), measured by clinical assessment and blood analysis.
Timepoint [2] 288030 0
6 months.
Secondary outcome [1] 298786 0
Nil
Timepoint [1] 298786 0
Nil

Eligibility
Key inclusion criteria
Patients will be eligible for inclusion if they fulfil the following criteria: between 18 and 80 years of age; glomerular filtration rate < 45 ml/min, stable known renal function over last 12 months; not requiring haemodialysis; haemoglobin < 120 g/L(Female), <130 g/L(Male); ferritin > 100 microg/L or transferrin saturation > 20% and not currently receiving ESA.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include: significant co-morbid conditions which in the opinion of the treating nephrologist preclude inclusion in the study; active gastrointestinal bleeding or another source of blood loss; haemolysis or other haematological disorder which reduces haemoglobin level; pregnancy or lactation. Intolerance to methlanthines (eg. caffeine, theophylline), recent peptic ulcer, recent cerebral or retinal haemorhage and acute MI.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Suitable patients will be identified from chronic renal databases, approached in writing or by telephone and asked if they would like to participate. After opportunity to read information and ask questions, written informed consent will be obtained. Participants will attend a research clinic on a monthly basis for laboratory and clinical assessment.
The person who determined if a subject was eligible for inclusion in the trial was unaware to which group the subject would be allocated, because this was carried out in pharmacy department completely independent of the other study personnel.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blinded allocation of treatment is performed by the hospital pharmacy for 50/50 active treatment to placebo.
Simple randomisation using dice-rolling was used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/10/2011
Actual
19/10/2011
Date of last participant enrolment
Anticipated
Actual
5/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285829 0
Government body
Name [1] 285829 0
SHRAC Research Translation Project
Country [1] 285829 0
Australia
Primary sponsor type
Individual
Name
Professor John OLYNYK FRACP MD
Address
Consultant Gastroenterologist
PO Box 480
Fremantle Hospital
WA 6959
Country
Australia
Secondary sponsor category [1] 284653 0
Individual
Name [1] 284653 0
Professor Paolo FERRARI FRACP
Address [1] 284653 0
Consultant Nephrologist
PO Box 480
Fremantle Hospital
WA 6959
Country [1] 284653 0
Australia
Other collaborator category [1] 277020 0
Individual
Name [1] 277020 0
Professor Debbie Trinder PhD
Address [1] 277020 0
School of Medicine and Pharmacology,
University of Western Australia,
T Block, Fremantle Hospital
Alma St
Fremantle WA 6160.
Country [1] 277020 0
Australia
Other collaborator category [2] 277021 0
Individual
Name [2] 277021 0
Professor Robert Trengrove PhD
Address [2] 277021 0
South Street campus
Murdoch University
90 South Street
Murdoch
Western Australia 6150
Country [2] 277021 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287848 0
South Metropolitan Health Service HREC
Ethics committee address [1] 287848 0
c/- Fremantle Hospital
PO Box 480
Fremantle WA 6959
Ethics committee country [1] 287848 0
Australia
Date submitted for ethics approval [1] 287848 0
Approval date [1] 287848 0
11/10/2010
Ethics approval number [1] 287848 0
1/10/0372

Summary
Brief summary
90% of subjects undergoing dialysis for chronic kidney disease (CKD) require regular treatment of anaemia with iron and erythropoiesis stimulating agents (ESAs), costing in excess of $150 million per year. Anaemia results from deficient production of erythropoietin and reduced Fe absorption and utilization. The latter results from excessive production of hepcidin in response to elevated interleukin 6 (IL6) levels. Recently, we conducted a 4-week pilot study of pentoxifylline (PTF) in anaemic patients with CKD and showed it was effective at reducing serum IL6 levels and improving haemoglobin levels. In this study we will determine longer-term efficacy by administering PTF to anaemic CKD patients for 6 months. If successful, we would recommend that therapy with PTF, which is 5% the cost of ESA therapy, could become the standard of care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34587 0
Prof John OLYNYK FRACP MD
Address 34587 0
Fremantle Gastroenterological Departmemt Fremantle Hospital PO Box 480 Fremantle WA 6959
Country 34587 0
Australia
Phone 34587 0
+61 08 9431 3333
Fax 34587 0
Email 34587 0
[email protected]
Contact person for public queries
Name 17834 0
Professor John OLYNYK FRACP MD
Address 17834 0
Fremantle Gastroenterological Departmemt
Fremantle Hospital
PO Box 480
Fremantle WA 6959
Country 17834 0
Australia
Phone 17834 0
+61 08 9431 3333
Fax 17834 0
Email 17834 0
[email protected]
Contact person for scientific queries
Name 8762 0
Professor John OLYNYK FRACP MD
Address 8762 0
Fremantle Gastroenterological Departmemt
Fremantle Hospital
PO Box 480
Fremantle WA 6959
Country 8762 0
Australia
Phone 8762 0
+61 08 9431 3333
Fax 8762 0
Email 8762 0
[email protected]

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No Supporting Document Provided



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