Study of Desmopressin for Prevention of Bleeding After Kidney Biopsy in Patients with Rare Glomerulonephritis

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What is this study about?

This clinical trial focuses on patients with rare glomerulonephritis, a kidney condition that requires a kidney biopsy for diagnosis. The study aims to evaluate whether a medication called desmopressin can help prevent bleeding complications after kidney biopsy procedures. The medication will be compared to a placebo to determine its effectiveness in reducing bleeding risks.

During the study, participants will receive either Minirin (which contains desmopressin) as an intravenous injection or a placebo before their kidney biopsy procedure. The medication is given as a single dose before the biopsy. Doctors will monitor patients for 24 and 48 hours after the procedure to check for any bleeding complications and changes in blood sodium levels.

The study will look at different types of bleeding events that might occur after the biopsy, including visible blood in urine and bruising around the kidney area. Doctors will also monitor other effects such as changes in heart rate and blood pressure. The overall hospital stay duration and cost-effectiveness of using this medication will be evaluated as part of the study.

1 Initial medical assessment

Your doctor will check your initial blood test results, including hemoglobin (must be above 8g/dl) and blood platelets (must be above 100,000/µL)

Your blood pressure will be measured to ensure it is below 160 mmHg

The doctor will check if there is no inflammation at the planned biopsy site

2 Medication administration

You will receive either desmopressin (4 micrograms/ml) or a placebo through an intravenous injection

The medication or placebo will be given before the kidney biopsy procedure

3 Kidney biopsy procedure

A needle biopsy of your kidney will be performed according to standard medical procedures

The procedure will be done on your natural kidney (transplanted kidneys are not included in this study)

4 24-hour monitoring period

Medical staff will monitor you for any bleeding events

Your blood will be tested to check hemoglobin levels

An ultrasound examination will be performed to check for any silent bleeding

Your sodium levels will be measured

Your heart rate and blood pressure will be monitored

5 48-hour follow-up

Your sodium levels will be checked again

Medical staff will continue to monitor for any complications

6 Hospital discharge

You will be discharged from the hospital when your doctor confirms it is safe

The length of your hospital stay will be recorded as part of the study data

Who Can Join the Study?

Must be at least 18 years old
Must be able to understand and sign an informed consent form
Must be qualified by a kidney specialist (nephrologist) for a kidney biopsy according to current medical standards (transplanted kidney biopsy is not allowed)
Must have:
- Blood hemoglobin level above 8g/dl
- Blood platelet count above 100,000 per microliter
Must have normal blood clotting test results (APTT and INR)
Must have controlled blood pressure with systolic pressure below 160 mmHg
If taking blood-thinning medications, only allowed to use:
- Aspirin (acetylsalicylic acid)
- Regular or low molecular weight heparin
Must have no skin infection or inflammation at the site where the biopsy needle will be inserted

Who Cannot Join the Study?

Age below 18 years or above 65 years
Known bleeding disorders (conditions that affect blood clotting)
Current use of blood-thinning medications (anticoagulants)
Uncontrolled high blood pressure (hypertension)
History of severe allergic reactions to desmopressin or similar medications
Current kidney infection or active urinary tract infection
Severe kidney dysfunction requiring dialysis
Pregnancy or breastfeeding
Current participation in other clinical trials
Heart failure or significant heart problems
History of blood clots (thrombosis)
Severe electrolyte imbalances (abnormal levels of minerals in blood)
Active infection or fever
Liver disease affecting blood clotting
Unable to provide informed consent

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Wojewodzki Szpital Specjalistyczny W Olsztynie	Olsztyn	Poland
Smgpwlj Upmjknetfssds W Ktbdwocs	Cracow	Poland
Petpomofq Ilaobgba Mllxhcpa Mqxuqnaowpof Sncpc Wqzdqtzghdfb I Awchwuzrumunx	Warsaw	Poland
Uaceutrzetcice Cfvzjzk Klygjmdwi	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	01.07.2021

Trial locations

Investigated drugs:

DESMOPRESSIN ACETATE

Desmopressin is a synthetic form of a natural hormone that helps control bleeding. It works by helping your blood to clot more effectively. In this trial, it is being studied as a preventive medication given before kidney biopsy procedures to reduce the risk of bleeding complications. This medication is commonly used in patients with certain bleeding disorders and can temporarily increase blood clotting factors.

Investigated diseases:

Glomerulonephritis

Glomerulonephritis – A kidney disease that occurs when the glomeruli, tiny filters in the kidneys, become inflamed and damaged. The condition can develop suddenly (acute) or gradually (chronic), affecting how the kidneys filter waste and excess fluid from the blood. It can cause swelling in various body parts, changes in urination patterns, and the appearance of blood or protein in the urine. Glomerulonephritis may be triggered by various factors including infections, immune system problems, or other underlying diseases. The rare and ultra-rare forms of glomerulonephritis represent uncommon variants of this condition that affect a very small number of people.

Trial ID:

2024-516270-30-00

Protocol code:

2021/ABM/01/00010

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Desmopressin for Prevention of Bleeding After Kidney Biopsy in Patients with Rare Glomerulonephritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?