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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | 0,3ug/kg in 100ml 0,9% NaCl managed as intravenous infusion; |
|
| Placebo comparator | Placebo Comparator | 0,9% NaCl managed as intravenous infusion; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desmopressin | Drug | desmopressin 0,3ug/kg in 100ml 0,9% NaCl managed as intravenous infusion; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding events in 24 hours after the procedure |
| 24 hours after kidney biopsy |
| Bleeding events in 48 hours after the procedure |
| 48 hours after kidney biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospitalization | Hospitalization time from kidney biopsy till discharge | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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
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 :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alicja Rydzewska-Rosołowska, Assoc.Prof. | Contact | +48 604 330 187 | alicja.rydzewska-rosolowska@umb.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Alicja Rydzewska-Rosołowska, Assoc.Prof. | Second Department of Nephrology and Hypertension with Dialysis Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| II Department of Nephrology and Hypertension | Recruiting | Bialystok | 15-276 | Poland |
All de-identified information will be shared upon asking.
Immediately following publication up to 5 years after.
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
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| ID | Term |
|---|---|
| D003894 | Deamino Arginine Vasopressin |
| ID | Term |
|---|---|
| D001127 | Arginine Vasopressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
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| intravenous infusion NaCl | Drug | 0,9% NaCl managed as intravenous infusion |
|
|
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |