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 May 2019)

The Kidney Optimal Health Program: A wellbeing trial for people with chronic kidney disease

Purpose: To improve mental health and overall wellbeing in people with stage 4 or 5 kidney disease who may be about to start or have commenced dialysis

Contact: Elizabeth Ayre or Carolee Coco at St Vincent’s Hospital Melbourne - [email protected] or (03) 9231 3427

Treatment of Proteinuria Due to Treatment Resistance or Treatment Intolerant Idiopathic FSGS

Purpose: To examine the effect of H.P. Acthar® Gel (corticotropin injection) in adult subjects with idiopathic focal segmental glomerulosclerosis (FSGS) who have failed to achieve remission with, or who are intolerant of, 1 or more previous immunosuppressive therapies.

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT02633046

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

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

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

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

Efficacy and Safety Study to Evaluate Vadadustat for the Correction of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT Correction)

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT02648347

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

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

Living Kidney Donor Study (LKD)

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)

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)

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

Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT03029208

Recruiting Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT03409107

Recruiting Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)

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

NCT03400033

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

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

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

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)

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)

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

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

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

Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy (Nefigard)

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT03643965

A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD Patients (STAGED-PKD)

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT03523728

Safety and Effectiveness of Propagermanium in Focal Segmental Glomerulosclerosis Participants Receiving Irbesartan (ACTION)

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT03649152

Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease (ACHIEVE)

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT03020303

Study of Safety and Efficacy of LNP023 in Patients With Kidney Disease Caused by Inflammation

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT03373461

A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy (PROTECT)

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT03762850

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

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

Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk

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

NCT03315143

Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis (VALOR CKD)

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT03710291

A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD Patients

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT03523728

Recruiting Biomarker Rule in/Out in Patients With Acute Diseases for Validation of AKI (BRAVA) Acute Kidney Injury

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT03754023

Recruiting Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT03493685

A Proof of Concept Study for a 12 Month Treatment in Patients With C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT03459443

A Study of CCX140-B in Subjects With FSGS

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT03628677

REVERSE-AKI Randomized Controlled Pilot Trial

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT03251131

An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis

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

NCT03943147

Atypical Hemolytic-Uremic Syndrome (aHUS) Registry

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT01522183

Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic FSGS

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT02633046

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

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

A Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis

More information visit ClinicalTrials.gov and search the unique trial identification number: NCT03393013

An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis

More information visit ClinicalTrials.gov and search the unique trial identification number:  NCT03385564

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

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

Protection Against Incidences of Serious Cardiovascular Events Study (PISCES)

More information visit https://aktn.org.au/pisces/

Better Evidence for Selecting Transplant Fluids (BEST-Fluids)

More information visit https://aktn.org.au/best-fluids/

IMpact of Phosphate Reduction On Vascular End-points in Chronic Kidney Disease (IMPROVE CKD)

More information visit https://aktn.org.au/improve-ckd/

A randomised Controlled trial of slowing of Kidney Disease progression From the Inhibition of Xanthine oxidase (CKD FIX)

More information visit https://aktn.org.au/ckd-fix/

Randomised Evaluation of SOdium dialysate Levels on Vascular Events: A cluster clinical study (RESOLVE)

More information visit https://aktn.org.au/resolve/

Clinical trials connection tool

The Clinical Trial Finder only searches for trials listed on clinicaltrials.gov. Other trials may be available.  Ask your healthcare professional about other trials which may be suitable for you.

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