Not recruitingRare disease

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

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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)
Step 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
Step 5
48-hour follow-up
Your sodium levels will be checked again
Medical staff will continue to monitor for any complications
Step 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 trial?

10 criteria

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)
check
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
- check
  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 trial?

15 criteria

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

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Szpital Uniwersytecki W Krakowie
Cracow, Poland
Verified
Uniwersytecki Szpital Kliniczny W Bialymstoku
Bialystok, Poland
Verified
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

DESMOPRESSIN ACETATE

What is already known about the treatment

Desmopressin – A synthetic hormone medication administered as a nasal spray, tablet, or injection that acts as a substitute for vasopressin, a natural hormone that helps control blood loss by promoting blood clotting. This medication is widely used in medical practice and has been extensively studied in clinical trials for preventing bleeding complications during invasive procedures, particularly in kidney biopsies and other surgical interventions. Desmopressin works at the molecular level by stimulating the release of blood-clotting factors (von Willebrand factor and Factor VIII) from blood vessel walls and increasing the concentration of these factors in the bloodstream, while also promoting the constriction of blood vessels. It belongs to the pharmacological class of vasopressin analogues and antidiuretic hormones, commonly prescribed for patients undergoing procedures with high bleeding risk or those with certain bleeding disorders.

Investigated diseases

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.