A clinical trial is a medical research study that aims to find a better way to treat a particular disease or fix a medical problem.

During the trial, the therapy or drug being tested is given to a group of volunteers. Information is then collected by doctors and nurses on how well the treatment worked. Data is also collected on side effects. Doctors use results from clinical trials to decide which treatments are best for patients like you.

Why do I have to sign a consent form to participate in a trial?

 Informed consent is one of the most important parts of the trial process. It is important that when you volunteer, you are given all of the information you need to make up your mind whether you want to take part. It is your right to ask as many questions as you want of your doctor or nurse until you are sure you understand what the trial involves. You can also take the information sheet home and discuss it with a family member or friend before you agree to take part. By signing the consent form, you are confirming that you have been given the form and that you understand this information. You should not sign the form unless you understand what you are being asked to do.

All clinical trials are required to be reviewed and approved by an Ethics Committee

 The Ethics Committee is an independent group of medical, scientific and legal experts, as well as lay members of the community, who decide if the trial is safe and fair to trial participants. The information sheet you will receive will have the contact details of the Ethics Committee who approved that trial. If something about the trial troubles you and you wish to discuss it with a person not directly involved in the trial, the Ethics Committee can be contacted.

 If you choose not to participate in a clinical trial, you will not be treated any differently by your doctor or nurse. It is your body and your health, and you should not feel pressured to do anything you are not comfortable with.

A clinical trial is a medical research study that aims to find a better way to treat a particular disease or fix a medical problem.
During the trial, the therapy or drug being tested is given to a group of volunteers. Information is then collected by doctors and nurses on how well the treatment worked. Data is also collected on side effects. Doctors use results from clinical trials to decide which treatments are best for patients like you.

 

Considerations

Are there any benefits in participating in a clinical trial?

 There a several potential benefits to participating in research:

-By being provided with access to information about the trial, you may gain a greater understanding of your disease, and the possible treatments for it.

-By participating in a research trial, you are able to play an active role in your health care.

-If you participate in a clinical trial, you may be given access to treatments or tests that are not available to the general public.

-You may be followed up more closely if you are a trial volunteer, which might mean more or longer clinic visits, or more in-depth tests at those visits.

Other patients in the future may benefit from the knowledge gained during the clinical trial.

How do I know if I’m right for a clinical trial?

The trials select people with specific diseases, with certain symptoms, on specific modes of renal replacement therapy, and on specific medications. Talk to your doctor or nurse about which trials you might be able to be a part of. If there are no AKTN clinical trials that are suitable for you at your clinic, there might be a locally run trial that you can be a part of. Not all patients with kidney disease will be suitable for participating in trials.

How do I sign up?

The first thing to do is talk to your treating doctor or nurse. They will be able to tell you which trials are being run at your clinic or hospital, and which you are suitable for. If there is a trial that you are suitable for, they will guide you through the information and consent process.

Useful websites

Where can I get more information about clinical trials?

  • The Australasian Kidney Trials Network (AKTN) - A group of nephrologists and other doctors, nurses, researchers, dietitians, scientists and other health professionals who conduct clinical trials in kidney disease. Because of their interest in renal disease and kidney health, they want to find better treatments for people living with kidney disease.

The AKTN's vision is to be an investigator-led clinical research organisation working with the kidney care community to achieve world class, innovative solutions that make meaningful differences to people with kidney disease. To achieve this, the AKTN designs, conducts and supports clinical trials and fosters clinical trials expertise in Australia and New Zealand in conjunction with global collaborators.

All AKTN clinical trials are designed with patients with kidney disease in mind. A patient with kidney disease sits on the AKTN Scientific Committee to make sure AKTN trials consider quality of life, symptoms and treatments important to people living with kidney disease.

Current trials

(Last updated July 2017)

Dose Escalation Study of VS-505 in End Stage Renal Disease Patients Undergoing Hemodialysis

Purpose: To evaluate the tolerability, safety and efficacy of VS-505 when given with meal for 8 weeks to hemodialysis patients with hyperphosphatemia

Study Type: Interventional 

Age: 18 and over

Sex: All

Location:

WA – Perth

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT02469467

 

Randomised Evaluation of Sodium Dialysate Levels on Vascular Events (RESOLVE)

Purpose: This global study will assess the effect of randomising dialysis sites to one of two default dialysate sodium concentrations in current practice, 140mmol/l and 137mmol/l, on major cardiovascular events and death in patients receiving maintenance haemodialysis.

Study type: Interventional

Age: Child, Adult, Senior

Sex: All

Location:

NSW - Concord Repatriation and General Hospital, Sydney

QLD - Princess Alexandra Hospital, Brisbane

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT02823821

Safety and Efficacy Study of Adjuvanted Prophylactic Hepatitis B Vaccine

Purpose: There is a need for more effective and better-tolerated hepatitis B vaccines for low responder high-risk populations including patients with renal impairment and/or diabetes mellitus and those aged over 40 years. Several approaches are available to enhance the potency of hepatitis B virus vaccines including use of the more highly immunogenic antigens, replacing alum with potentially more effective adjuvants, and increasing the dose of vaccine antigen. A combination of these strategies is being tested in this study to identify the most promising candidate approaches to take forward into advanced clinical development

Study type:

Age: 18 or over

Sex: All

Location:

SA - Flinders Medical Centre

More information visit ClinicalTrials.gov and search the unique trial identification number:

NCT01951677 

 

Sleep Apnoea in Haemodialysis

Purpose: Sleep disturbance is a significant issue in people undergoing dialysis. More than 80% of haemodialysis patients complain of difficulty sleeping. Inadequate sleep can cause poor daytime function and increased risk of motor vehicle incidents.

One of the common reasons for sleep disturbance in dialysis patients is sleep apnoea. Sleep apnoea involves pauses in breathing that occur during sleep. Each pause can last only a few seconds or minutes. Severe sleep apnoea reduces oxygen supply and increases risk of heart attack and stroke, which are the leading causes of death in dialysis patients.

In this project, the investigators will examine how a change of dialysis treatment might improve sleep. This project will first identify patients at risk of sleep disturbance using surveys and a subsequent sleep study. The investigators will then test different dialysis models to see the effect of dialysis treatment on sleep apnoea. The aim is to find a dialysis model that works better for patients with sleep apnoea

Study type: Interventional

Age: 18 years and over

Sex: All

Location:

NSW - John Hunter Hospital, Newcastle

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT02939586

Standard vs. Accelerated Initiation of RRT in Acute Kidney Injury (STARRT-AKI: Principal Trial)

Purpose: The objectives of this trial are to determine whether, in critically ill patients with severe acute kidney injury (AKI), randomization to accelerated initiation of renal replacement therapy (RRT), compared to standard initiation, leads to:

1. Improved survival (primary outcome); and

2 .Recovery of kidney function (principal secondary outcome), defined as independence from RRT at 90 days

Study type: Interventional

Age: 18 years and over

Sex: All

Locations: QLD - Princess Alexandra Hospital, Woolloongabba; Nambour General Hospital, Nambour

VIC; Austin Hospital, Heidelberg; The Alfred Hospital, Melbourne; Western Health (Footscray Hospital and Sunshine Hospital), St Albans

NSW; Nepean Hospital, Kingswood; Royal Prince Alfred Hospital, Sydney

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT02568722

Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

Purpose: A multicentre, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anaemia in subjects with NDD-CKD

Study type: Interventional

Age: 18 years and over

Sex: All

Location:

NSW - Liverpool, Westmead

QLD - Cairns

SA - Adelaide

VIC - Clayton

WA - Murdoch, Nedlands

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT02680574

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD)

Purpose: The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.

Study type: Interventional

Age: 18 years and over

Sex: All

Location:

ACT - Garran

NSW - Gosford, Liverpool, New Lambton Heights, Wollongong

SA - Adelaide

VIC; Fitzroy, Heidelberg, Richmond, St. Albans, Box Hill, Elizabeth Vale, Reservoir

WA - Fremantle

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT02540993

Global, Multicentre, Non Interventional Advagraf Conversion Registry in Kidney Transplant Patients (CHORUS)

Purpose: A study to evaluate changes over time in renal function from baseline (time of conversion) up until five years post conversion in kidney transplant patients converted from tacrolimus twice daily (BD) formulations to a once daily formulation as Advagraf.

Study type: Interventional

Age: 18 years and over

Sex: All

Location:

NSW – Gosford; New Lambton; Westmead

SA - North Adelaide

WA – Nedlands; Perth

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT02555787

A Study of FG-4592 for the Treatment of Anemia in Chronic Kidney Disease Patients Not Receiving Dialysis

Purpose: The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anaemia in chronic kidney disease patients who are not on dialysis.

Study type: Interventional

Age: 18 years and over

Sex: All

Location:

NSW - Liverpool; Gosford; Randwick; New Lambton Heights

TAS - Launceston

VIC – Melbourne; Parkville

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT01750190

QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant (ReGIFT)

Purpose: The purpose of this trial is to evaluate the reduction in incidence and severity of delayed graft function with kidney allografts from donors >45 years after brain death (DBD).

Study type: Interventional

Age: 18 years and over

Sex: All

Location:

NSW - John Hunter Hospital; New Lambton; Westmead Hospital

QLD - Princess Alexandra Hospital; Woolloongabba

SA - Royal Adelaide Hospital

VIC - Royal Melbourne Hospital

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT02610296

Living Kidney Donor Study (LKD)

Purpose: Living kidney donors and non-donor controls will be studied before and after the living donor transplant. The donor and non-donor will be followed for up to 5 years. The purpose of this study is to see if there are any differences between the two groups in regards to blood pressure, rate of hypertension, kidney function and psychological well being and economical status.

Study type: Observational

Age: 18 years and over

Sex: All

Location:

WA - Sir Charles Gairdner Hospital Recruiting, Perth

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT00936078

Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study (TESTING Low Dose Study) (TESTING)

Purpose: This study will evaluate the long-term efficacy and safety of low dose oral methylprednisolone compared to matching placebo, on a background of routine RAS inhibitor therapy, in preventing kidney events in patients with IgA nephropathy and features suggesting a high risk of progression.

Study type: Interventional

Age: 18 years and over

Sex: All

Location:

NSW - Concord Repatriation and General Hospital; Royal North Shore Hospital

SA - Royal Adelaide Hospital

VIC - Royal Melbourne Hospital Recruiting

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT01560052

Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)

Purpose: The purpose of this multi-center event-driven study in non-dialysis (ND) participants with anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.

Study type: Interventional

Age: 18 to 99 years

Sex: All

Location:

NSW - Gosford

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT02876835

Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis

Purpose: The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within the therapeutic range, and select the target dose for phase III development.

Study type: Interventional

Age: 18 to 70 years

Sex: All

Location:

NSW - The Prince of Wales Hospital, Randwick

QLD - Princess Alexandra Hospital-Nephrology, Wolloongabba

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT02770170

ATHENA: Natural History of Disease Study in Alport Syndrome Patients (RG012-01)

Purpose: There is limited published clinical data about the natural history of renal disease in Alport syndrome. The RG012-01 study will collect data to characterize the progression of renal dysfunction in Alport syndrome patients.

Age: 12 to 65 years

Sex: All

Location:

NSW - New Lambton

VIC - Parkville,

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT02136862

Effect of Farxiga on Renal Function and Size in Type 2 Diabetic Patients With Hyperfiltration (Hyper)

Purpose: The investigators propose to treat newly diagnosed, hyperfiltering T2DM patients with or without microalbuminuria with dapagliflozin or metformin for 4 months. The metformin-treated group will serve as controls for improved glycemic control, since the investigators have shown that insulin therapy to normalize A1c reduces hyperfiltration and kidney size in T1DM patients.

Study type: Interventional

Age: 30 to 70 years

Sex: All

Location:

VIC - Baker Medical Research Institute and Alfred Hospital, Melbourne

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT02911792

Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function (BALANCE)

Purpose: This is a randomized, double blind, active control study of PRX-102 in Fabry disease patients with impaired renal function. Patients treated for at least 1 year with agalsidase beta and on a stable dose for at least 6 months will be screened and then randomized to continue treatment with either agalsidase beta at the same dose or to treatment with 1 mg/kg of PRX-102. The identity of the enzyme will be blinded to the patient and the investigator. Patients will receive intravenous infusions every two weeks. Patients will be randomized in a 2:1 ratio of PRX-102 to agalsidase beta. Randomization will be stratified by urinary protein to creatinine ratio (UPCR) of < or ≥ 1 g/g by spot urine sample.

Study type: Interventional

Age: 18 to 60 years Sex: All

Location:

VIC - Royal Melbourne Hospital, Melbourne

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT02795676

Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis (TULIP-LN1)

Purpose: The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with active proliferative lupus nephritis (LN).

Study type: Interventional

Age: 18 to 70 years

Sex: All

Location:

SA – Adelaide

VIC – Clayton; Parkville

NSW – Westmead; Woolloongabba; Liverpool

QLD - Herston

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT02547922

A Study to Evaluate the Effect of Dapagliflozin With and Without Saxagliptin on Albuminuria, and to Investigate the Effect of Dapagliflozin and Saxagliptin on HbA1c in Patients With Type 2 Diabetes and CKD

Purpose: The purpose of this clinical research study is to determine whether dapagliflozin alone or in combination with saxagliptin can decrease albuminuria and improve glycemic control in patients with Type 2 diabetes, albuminuria and renal impairment (CKD).

Study type: Interventional

Age: 18 to 130 years

Sex: All

Location:

VIC - Box Hill; Campbelltown; Geelong

QLD - Herston

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT02547935

Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

Purpose: The purpose of the study is to assess the efficacy of ALXN1210 to control disease activity in adolescent and adult patients with aHUS who have not previously used a complement inhibitor.

Study type: Interventional

Age: 12 and over

Sex: All

Location:

VIC – Geelong

SA - Adelaide

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT02949128

A Proof-of-Mechanism Study to Determine the Effect of ACH-0144471 on C3 Levels in Patients With C3G or IC-MPGN

Purpose: The purpose of this study is to determine the effect of ACH-0144471 on C3 levels in patients with C3G or IC-MPGN.

Age: 16 to 65 years

Sex: All

Location:

VIC – The Royal Melbourne Hospital, Melbourne

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT03124368

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