More Information for Participants

Implementation of Metformin theraPy to Ease DEcline of kidney function in Polycystic Kidney Disease (IMPEDE-PKD) Randomised Placebo-Controlled Trial

We are inviting you to take part in a research study. This information is in addition to the information found here.

Summary of trial activities

More information

More information on Autosomal Dominant Polycystic Kidney Disease (ADPKD): https://pkdaustralia.org

What are the risks or side effects of metformin?

Further information about metformin
Information on complaints, compensation and the ethics committee that approved this study
What if I suffer and injury or complications because of the study?

You should contact the research team as soon as possible and you will be assisted with arranging appropriate medical treatment. If you are eligible for Medicare, you can receive any medical treatment required to treat the injury or complication, free of charge, as a public patient in any Australian public hospital.

Who can help if I have concerns about the study?

For matters relating to research at the site at which you are participating, the details of the local site complaints person are:

Complaints contact person
Name[Name]
Position[Position]
Telephone[Phone number]
Email[Email address]

If you have any complaints about any aspect of the project, the way it is being conducted or any questions about being a research participant in general, then you may contact your local HREC administrator for the requirements at your institution.

Reviewing HREC approving this research and HREC Executive Officer details
Reviewing HREC name Metro South Health Ethics Compliance Team
HREC Executive Officer N/A
Telephone 07 3443 8047
Email MSH-Ethics@health.qld.gov.au
What if I have complaints regarding my MBS/PBS information?

If you have a privacy complaint in relation to the use of your MBS/PBS information you should contact the office of the Australian Information Commissioner:

Websitehttp://www.oaic.gov.au
Telephone1300 363 992
Emailenquiries@oaic.gov.au
MailGPO Box 5218, Sydney NSW 2001

What happens if the trial is stopped unexpectedly and how you will be kept informed if new information arises during the study?
What if new information arises during this study?

Your trial doctor will tell you about any new information and discuss with you whether you want to continue in this research. Your trial doctor might consider it to be in your best interests to withdraw you from this research. If this happens, he/she will explain the reasons and arrange for your regular health care to continue.

Could this study be stopped unexpectedly?

Research projects may be stopped unexpectedly for a variety of reasons such as:

  • Unacceptable side effects
  • The drug being shown not to be effective
  • The drug being shown to work and not need further testing
  • Decisions made by local regulatory/health authorities.

Your doctor will let you know what options you have.

Why does this study use randomisation to choose your group?

Sometimes we do not know which treatment is best for treating a condition. To find out, we need to compare different treatments. This clinical trial will compare metformin with a placebo. A placebo is a medication with no active ingredients. You will be randomly allocated to either take metformin (the treatment group) or the placebo (the control group) The results from each group will be compared at the end of the trial to see if one is better.

Neither you nor your trial doctor will know which treatment you are receiving. In special circumstances, for example a medical emergency your trial doctor can find out which treatment you are receiving.

This study has been designed to make sure the researchers interpret the results in a fair and appropriate way and avoids trial doctors or participants jumping to conclusions. 

Medications to avoid while taking the study medication

How will my information and confidentiality be protected?

By signing the consent form, you consent to the trial doctor and relevant research staff collecting and using personal information about you for the study. Information about you may be obtained from your health records held at this and other health services for the purpose of this research.

Any information obtained in connection with this research that can identify you will remain confidential and stored securely. After enrolment, you will be given a unique ID. The research/trial data will be collected using this ID, not your name or any other identifiable information (e.g., date of birth, hospital UR number). Any information with your name or any other identifiable information is only accessed by the staff involved in this research who have completed training for ensuring confidentiality of research participants.

Your personal and health information collected for this study will be stored beyond the term of this project for both regulatory and potential new research purposes. It is only released to doctors or hospitals involved in your care, or with your consent for future research purposes or where an ethics committee has granted approval for non-identifiable information to be used without your consent as allowed under law. No identifying information is ever released publicly.

Your health records and any information obtained during the study are subject to inspection (for the purpose of verifying the procedures and the data) by the relevant authorities and authorised representatives of the Australasian Kidney Trials Network at the University of Queensland, [Name of institution], or as required by law. By signing the Consent Form, you authorise release of, or access to, this confidential information to the relevant research personnel and regulatory authorities as noted above.

It is anticipated that the results of this study will be published and/or presented in a variety of forums. In any publication and/or presentation, information will be provided in such a way that you cannot be identified, except with your permission. Reference will be made to the study ID only, not to any identifiable information. 

Information about your participation in this study may be recorded in your health records. In accordance with relevant Australian and/or [Name of state/territory] privacy and other relevant laws, you have the right to request access to your information collected and stored by the research team. You also have the right to request that any information with which you disagree be corrected. Please contact the research team member named at the end of this document if you would like to access your information.

Other information collected

We will collect information on how many health services you use during the study. You are asked to consent for study researchers to access your Medicare Benefits Scheme (MBS) and Pharmaceutical Benefits Scheme (PBS) data.

  • MBS collects information on medical visits, tests and procedures
  • PBS collects information on prescription medicines.

At the end of the study, the researchers will request your data from Services Australia. To collect your MBS and PBS information, your personal information (Medicare card number, name, date of birth, sex and address) will be securely sent to Services Australia.

When we request this information, there is a small risk to your privacy. However, when we receive these data from the health department, a unique identification number will replace your personal information. This should reduce the risk to your privacy. To ensure your confidentiality, we will also adhere to strict guidelines for data transfer, data storage and data access.

Information about inpatient hospital admissions, emergency department visits, survival, use of medications, outpatient services and cost of each visit at the hospital will be requested from state government data custodians. This is called Data Linkage. To get your health information using Data Linkage, the study team will collect personal information about you, including your hospital UR number, name, date of birth, gender and address. The study sponsor (The University of Queensland) will collect, store, and send the above personal details to the Data Linkage office in a safe manner. Using these details, the study team will link your study information with state government health information. Once it is linked, all personal information (including name, date of birth and address) will be removed. 

To maintain confidentiality of your information, we have processes in place. These include removing information that can tell who you are, using study numbers and following strict guidelines about data transfer, storage and access. If you decide to withdraw your consent for data linkage, the study team this information will not request this information from state government. The data obtained from state linkage will not be shared with external researchers for future unspecified study.

What will happen to my test samples (additional information)

Researchers are trying to learn more about ADPKD and how your body reacts to metformin. You are also being asked to provide consent for the collection of extra blood during some of your study visits. This blood will be frozen and stored in a confidential manner for testing later. Your samples will be labelled with a study code only, not your name, address or hospital number. These samples will be tested at a laboratory in Australia or at a research laboratory outside Australia explicitly approved by the trial global steering committee and which is included within the ethical approval of this trial within that country.

Although the chance is low, if blood and urine sample tests incidentally find any health-related issues, you and your treating doctor/s will be notified as soon as practicable for further assessment and to seek appropriate treatment.

Your samples may also be used for future collaborative research studies related to ADPKD not yet thought of. These future research studies will only use your samples with the approval from a Human Research Ethics Committee. We don’t know how long these samples will be stored and you won’t be informed of the results of these tests.

Will you be doing any genetic tests? [Delete if not applicable at the site name].

You are also be asked if the researchers can keep an extra blood sample to test for genetic (DNA) markers. Genetic research looks specifically at your DNA (which is passed down from your parents). This genetic testing will only be carried out for the purpose of ADPKD and chronic kidney disease-related research purposes. In this research, we will not be testing for or analysing other genes known as actionable incidental finding associated genes. There are approximately 59 such genes at present and they can be associated with some forms of inheritable cancers and nervous system conditions and are beyond the scope of this research. However, we may identify other genes that could indicate other health-related issues. If this occurs, you and your treating doctor/s will be notified as soon as practicable to find specific services to seek genetic guidance. You can decline to be informed of these findings in the consent form.

None of your genetic related information will be used for any purpose other than this study without seeking your further consent, unless required by law.

If you don’t want to consent to the collection of your samples for genetic testing, you can still participate in the study. You can decline genetic testing in the consent form.

What happens when the study ends?

After the study ends, your doctor will discuss the options you have with regards to the continuing treatment of your kidney disease. Once the study is complete and the results are known, a written plain English summary of the results of the study will be made available to your study staff. You can request a copy of this summary from the study staff.

What if I withdraw from this study?

You are under no obligation to continue with the research study. You may change your mind at any time about participating in the research. People withdraw from studies for various reasons and you do not need to provide a reason.

You can withdraw from the study at any time by completing and signing the ‘Participant Withdrawal of Consent Form’. This form is provided separately and is to be completed by you and supplied to the research team if you choose to withdraw at a later date.

If you decide to withdraw from this research, please notify a member of the research team before you withdraw. This notice will allow that person or the research supervisor to discuss any health risks or special requirements linked to withdrawing.

If you do withdraw your consent during the study, the trial doctor and relevant research staff will not collect additional personal information from you, although personal information already collected will be retained to ensure that the results of the study can be measured properly and to comply with law. You should be aware that data collected by the research team up to the time you withdraw will form part of the research results.  If you do not want them to do this, you must tell them before you join the study.

If you decide to withdraw from study treatment, you will be asked to attend follow-up visits to allow collection of information regarding your health status. Alternatively, the investigator/sponsor will request permission to access your medical records for collection of follow-up information for research and analysis.

Will I have to pay anything to be in this study?

No. The trial treatment and medical tests are provided by the sponsor. Your treatment will be free of charge to you in the same way it would be if you were not in this trial.

How does this research differ from standard care?

You will receive standard care regardless of whether you take part in the trial or not. If you decide to take part you will be asked to do some things in addition to standard care. These include taking the study medication, completing surveys and blood and urine tests. There will be some extra trial appointments as described in sections 3 and 4. 

Destruction of data

TBC

If at any time anything is unclear or you have any questions, please make sure to ask your doctor who would be happy to help and answer your questions.