Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Safety Outcomes Post Kidney Biopsy – randomized clinical Evaluation of Efficacy of Desmopressin

This research is investigating a medicine called desmopressin to see if it can make kidney biopsies safer for people with rare kidney diseases. A kidney biopsy is a procedure where a small piece of kidney tissue is removed for examination. Bleeding is a possible side effect, so this study aims to find out if desmopressin can prevent or reduce both minor and major bleeding events that can happen afterwards. Researchers will also be checking for any other side effects, like changes in salt levels in the blood. The goal is to see if desmopressin can improve safety and recovery for patients undergoing this important diagnostic procedure.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Medical University Of Bialystok

Enrolment target

454

Start

02 Dec 2024

Rare and ultra-rare glomerulonephritis

What is this study about?

This study is looking into a medicine called desmopressin and its potential to make kidney biopsies safer. A kidney biopsy is a common procedure where doctors take a very small sample of your kidney tissue to help understand your kidney condition better. While generally safe, sometimes people might experience bleeding after the biopsy. This can range from minor bleeding, like noticing some blood in your pee, to more serious issues that might need further medical attention.

The main goal of this research is to see if desmopressin can reduce these bleeding events. Researchers are carefully watching how many times people experience bleeding, both big and small, in the 24 hours after their biopsy. They are also looking closely at any other effects the medicine might have, such as changes in the salt balance in your blood, which is called hyponatremia. This information will help doctors understand if desmopressin is a helpful and safe option for patients needing a kidney biopsy.

The study focuses on people with rare kidney conditions known as glomerulonephritis. By collecting detailed information on side effects, recovery time, and overall safety, the researchers hope to improve care for these patients. They will also consider if using desmopressin offers good value, looking at how it might affect hospital stays and overall costs. This type of research, known as a Phase III trial, is a crucial step in determining if a new treatment should become a standard part of medical practice.

Key takeaways

This study investigates if desmopressin can reduce bleeding after kidney biopsies.
It focuses on adults with rare kidney diseases.
Researchers will monitor for bleeding and side effects, especially salt level changes.
The study compares desmopressin to a placebo.
It aims to improve safety for patients undergoing kidney biopsies.
Participation involves monitoring before and after the biopsy.

Who may be eligible?

To be part of this study, you need to be at least 18 years old – there's no upper age limit, so adults of any age can potentially join. The study is open to both men and women.

Crucially, you would need to have been diagnosed with a rare kidney condition called glomerulonephritis and be scheduled to have a kidney biopsy. Other specific health checks would also be done by the study team to make sure it's safe for you to take part and that the results of the study are as clear as possible. Your doctor or the study team will be able to explain these in more detail.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of a rare kidney condition called glomerulonephritis?
Are you scheduled to have a kidney biopsy?
Are you willing to potentially receive either the study drug or a placebo?
Are you able to attend study visits and have regular blood tests?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to the clinic. First, you'd have an initial visit to check if you're suitable for the study. If you are, you would then receive either the study medicine (desmopressin, given as an injection) or a placebo (a dummy injection that looks the same but contains no medicine) around the time of your kidney biopsy. Throughout the study, you would have regular blood tests to check your salt levels and other health markers, particularly in the 24 to 48 hours after your biopsy. Doctors would also monitor any bleeding and new symptoms you might have. The study team will explain the full schedule of appointments and tests, and the total time you would be involved.

Potential risks and benefits

Participating in any study has potential benefits and risks. A potential benefit could be that if you receive desmopressin, it might reduce your risk of bleeding after your kidney biopsy. However, there's no guarantee, and you might receive the placebo. Potential risks could include side effects from the medication, such as changes in your blood's salt levels or other reactions. The study team will carefully monitor you for any problems. You would be fully informed about all known risks before you decide to join, and you always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Poland

Common questions

What is a kidney biopsy?

A kidney biopsy is a procedure where doctors take a tiny piece of your kidney to examine it under a microscope, helping them understand your kidney condition.

What is desmopressin?

Desmopressin is a medicine that helps control how your body uses water and can also affect how your blood clots.

What is 'hyponatremia'?

Hyponatremia means your blood has a lower than normal level of sodium (a type of salt). It's a potential side effect that the study will monitor closely.

Will I know if I'm getting the medicine or a placebo?

No, in this type of study, you won't know if you're getting the active medicine or the placebo. This helps make the study results more reliable.

What are 'rare glomerulonephritis' conditions?

These are uncommon conditions that cause inflammation in the tiny filters of your kidneys, which are called glomeruli.