Kidney BiopsyPhase 3STOP-BLEEDNCT05467033
Safety Outcomes Post Kidney Biopsy - Randomized Clinical Evaluation of Efficacy of Desmopressin
A Phase 3 study testing Desmopressin and intravenous infusion NaCl in people with Kidney Biopsy, run by Medical University of Bialystok at 1 site in Poland.
Trial summary
It is a randomized, multicenter, double-blind, placebo controlled, interventional clinical trial that will be conducted in Poland, in about 6 Hospital Nephrology Departments to evaluate the safety and effectiveness of desmopressin on the prevention of bleeding after percutaneous needle kidney biopsy in patients with… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Kidney Biopsy
- What is being tested?
- Desmopressin and intravenous infusion NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 424 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2022to 31 Aug 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- Ability to provide Informed Consent
- Qualification by nephrologist to kidney biopsy in accordance to current standards
- Initial haemoglobin concentration > 8g/dl and PLT count >100 x103/μL
- Normal range of APTT and INR
- Blood pressure control defined as SBP<160 mmHg
- Permitted antiplatelet/antithrombotic drugs: acetylsalicylic acid and heparin
- No inflammation at the point of biopsy needle insertion
Who cannot join
- Initial sodium concentration <130mmol/l
- Pregnancy and breastfeeding
- Anaphylactic shock after desmopressin administration (medical history)
- Necessity of administration other anti-platelet / anti thrombotic drugs other than acetylsalicylic acid, non-fractionated heparin or low molecular weight heparin
- Decompensated Heart failure
- Von Willebrand disease (VWD) type II B
Show all 15Show fewer
- As per Investigator opinion a medical situation which may lead to increased intracranial pressure (ICP)
- Hydronephrosis of the biopsied kidney
- Usage of any prohibited drug before screening :
- ASA in dosage > 75mg per day
- Vitamin K antagonist (VKA)
- Direct oral anticoagulants (DOAC)
- Low-molecular-weight heparin (LMWH)
- Unfractionated heparin (UFH)
- Except situation when dosage of listed above drugs will be adjusted in accordance to protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alicja Rydzewska-Rosołowska, Assoc.Prof. contact
Poland1 site, 1 recruiting
- Recruiting
II Department of Nephrology and Hypertension
Bialystok, 15-276
Alicja Rydzewska-Rosolowska, MD, +48858317885, alicja.rosolowska@umb.edu.pl
About this study
It is a randomized, multicenter, double-blind, placebo controlled, interventional clinical trial that will be conducted in Poland, in about 6 Hospital Nephrology Departments to evaluate the safety and effectiveness of desmopressin on the prevention of bleeding after percutaneous needle kidney biopsy in patients with rare and ultrarare glomerulonephritis.
Read the detailed description
Glomerulonephritis (GN) are rare diseases which carry a high risk of morbidity and mortality. Very often it is diagnosed in the late stage of a disease. One of the reasons might be the fact of a concern for potential complications which might arise from kidney biopsy which is the only procedure which can confirm a diagnosis of glomerulonephritis. According to the map of health needs for Poland the estimated incidence of glomerulonephritis is 40.6 thousand people per year and approximately 1,250 percutaneous renal biopsy (PRB) are performed annually in the adult population.
There are few other studies which analyse the effect of DDAVP administration on the incidence of post-biopsy bleeding events in patients undergoing ultrasound guided PRB without previous coagulopathy. However, there were controversies regarding the potential side effects of DDAVP22 as the studies included only native kidneys biopsies Therefore, a clinical trial is planned with an adequately statistically powered sample of high-risk patients is planned Patients above 18 years old, already qualified by a nephrologist for a kidney biopsy will be randomized with random permuted blocks method into two equal groups (212 patients each) - in one 0,3 micrograms/kg i.v. of desmopressin (in 100 ml of 0,9% NaCl) will be administered one hour before procedure, in the second placebo only (100 ml of 0,9% NaCl). Kidney biopsy will be performed according to standard procedures by an experienced nephrologist with the use of 16G needles during a standard hospitalization with 48 hours of observation. The investigators will assess minor and major bleeding events occurring in the first 24 hours after the procedure (minor: macroscopic haematuria, clinically silent hematoma on kidney ultrasound performed 24 hours after the procedure, haemoglobin decrease above 20% from baseline; major: blood transfusion, embolization, nephrectomy, death indirectly or directly caused by the procedure) and for safety reasons the occurrence of hyponatremia 24 and 48 hours after kidney biopsy
- Conditions
- Kidney Biopsy
- Being tested
- Desmopressin, intravenous infusion NaCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
Also called Minirin
desmopressin 0,3ug/kg in 100ml 0,9% NaCl managed as intravenous infusion;
intravenous infusion NaClDrug
Also called 0,9% NaCl
0,9% NaCl managed as intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 0,3ug/kg in 100ml 0,9% NaCl managed as intravenous infusion; Receives: Drug: Desmopressin; Drug: intravenous infusion NaCl |
| Placebo comparator | Placebo comparator | 0,9% NaCl managed as intravenous infusion; Receives: Drug: intravenous infusion NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding events in 24 hours after the procedure
- Minor bleeding events: macroscopic hematuria; clinically silent hematoma in ultrasound performed 24h after biopsy, decrease in hemoglobin concentration >20% of baseline.
- Major bleeding events: erythrocyte transfusion, embolization, nephrectomy, death related directly or indirectly to bleeding.
Measured: 24 hours after kidney biopsy
Bleeding events in 48 hours after the procedure
- Minor bleeding events: macroscopic hematuria; clinically silent hematoma in ultrasound performed 24h after biopsy, decrease in hemoglobin concentration >20% of baseline.
- Major bleeding events: erythrocyte transfusion, embolization, nephrectomy, death related directly or indirectly to bleeding.
Measured: 48 hours after kidney biopsy
Secondary outcomes (1)
Length of hospitalization
Hospitalization time from kidney biopsy till discharge
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Sep 2022
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alicja Rydzewska-Rosołowska, Assoc.Prof., Principal investigator, Second Department of Nephrology and Hypertension with Dialysis Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467033
- Sponsor's protocol ID
- 2021/ABM/01/00100
- Acronym
- STOP-BLEED
- Status last verified
- May 2025
- First submitted
- 13 Jul 2022
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified information will be shared upon asking.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Outcomes Post Kidney Biopsy - Randomized Clinical Evaluation of Efficacy of Desmopressin
- ClinicalTrials.gov ID
- NCT05467033
- Acronym / sponsor ID
- STOP-BLEED / 2021/ABM/01/00100
- Conditions
- Kidney Biopsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is a randomized, multicenter, double-blind, placebo controlled, interventional clinical trial that will be conducted in Poland, in about 6 Hospital Nephrology Departments to evaluate the safety and effectiveness of desmopressin on the prevention of bleeding after percutaneous needle kidney biopsy in patients with rare and ultrarare glomerulonephritis.
Detailed description
Glomerulonephritis (GN) are rare diseases which carry a high risk of morbidity and mortality. Very often it is diagnosed in the late stage of a disease. One of the reasons might be the fact of a concern for potential complications which might arise from kidney biopsy which is the only procedure which can confirm a diagnosis of glomerulonephritis. According to the map of health needs for Poland the estimated incidence of glomerulonephritis is 40.6 thousand people per year and approximately 1,250 percutaneous renal biopsy (PRB) are performed annually in the adult population.
There are few other studies which analyse the effect of DDAVP administration on the incidence of post-biopsy bleeding events in patients undergoing ultrasound guided PRB without previous coagulopathy. However, there were controversies regarding the potential side effects of DDAVP22 as the studies included only native kidneys biopsies Therefore, a clinical trial is planned with an adequately statistically powered sample of high-risk patients is planned Patients above 18 years old, already qualified by a nephrologist for a kidney biopsy will be randomized with random permuted blocks method into two equal groups (212 patients each) - in one 0,3 micrograms/kg i.v. of desmopressin (in 100 ml of 0,9% NaCl) will be administered one hour before procedure, in the second placebo only (100 ml of 0,9% NaCl). Kidney biopsy will be performed according to standard procedures by an experienced nephrologist with the use of 16G needles during a standard hospitalization with 48 hours of observation. The investigators will assess minor and major bleeding events occurring in the first 24 hours after the procedure (minor: macroscopic haematuria, clinically silent hematoma on kidney ultrasound performed 24 hours after the procedure, haemoglobin decrease above 20% from baseline; major: blood transfusion, embolization, nephrectomy, death indirectly or directly caused by the procedure) and for safety reasons the occurrence of hyponatremia 24 and 48 hours after kidney biopsy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Desmopressin, Drug: intravenous infusion NaCl0,3ug/kg in 100ml 0,9% NaCl managed as intravenous infusion; |
| Placebo comparator | Placebo comparator | Drug: intravenous infusion NaCl0,9% NaCl managed as intravenous infusion; |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 18 years old
- Ability to provide Informed Consent
- Qualification by nephrologist to kidney biopsy in accordance to current standards
- Initial haemoglobin concentration > 8g/dl and PLT count >100 x103/μL
- Normal range of APTT and INR
Key exclusion criteria (15 listed)
- Initial sodium concentration <130mmol/l
- Pregnancy and breastfeeding
- Anaphylactic shock after desmopressin administration (medical history)
- Necessity of administration other anti-platelet / anti thrombotic drugs other than acetylsalicylic acid, non-fractionated heparin or low molecular weight heparin
- Decompensated Heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesmopressinAlso: Minirindesmopressin 0,3ug/kg in 100ml 0,9% NaCl managed as intravenous infusion; | Drug | Experimental |
| intravenous infusion NaClAlso: 0,9% NaCl0,9% NaCl managed as intravenous infusion | Drug | Experimental, Placebo comparator |
Primary outcome
Bleeding events in 24 hours after the procedure
Time frame: 24 hours after kidney biopsy
1. Minor bleeding events: macroscopic hematuria; clinically silent hematoma in ultrasound performed 24h after biopsy, decrease in hemoglobin concentration >20% of baseline. 2. Major bleeding events: erythrocyte transfusion, embolization, nephrectomy, death related directly or indirectly to bleeding.
Bleeding events in 48 hours after the procedure
Time frame: 48 hours after kidney biopsy
1. Minor bleeding events: macroscopic hematuria; clinically silent hematoma in ultrasound performed 24h after biopsy, decrease in hemoglobin concentration >20% of baseline. 2. Major bleeding events: erythrocyte transfusion, embolization, nephrectomy, death related directly or indirectly to bleeding.
1 secondary outcome
Length of hospitalization
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: Yes. All de-identified information will be shared upon asking.
Related trials for Kidney Biopsy
RecruitingObservational study
Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease
Malignant Neoplasms, Hereditary Neoplastic Syndromes
Not yet recruitingObservational study
Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
Renal Transplantation; Complication, Renal Transplant
RecruitingObservational study
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Brain Cancer, Breast Cancer
Active, not recruitingObservational study
Blood Biomarkers in Pediatric Kidney Transplant Recipients
Rejection of Kidney Allograft
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alicja Rydzewska-Rosołowska, Assoc.Prof. contact
Alicja Rydzewska-Rosołowska, Assoc.Prof. principal investigator
Second Department of Nephrology and Hypertension with Dialysis Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desmopressin and intravenous infusion NaCl in people with Kidney Biopsy, run by Medical University of Bialystok at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alicja Rydzewska-Rosołowska, Assoc.Prof. (+48 604 330 187, alicja.rydzewska-rosolowska@umb.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding events in 24 hours after the procedure (time frame: 24 hours after kidney biopsy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.