Severe Renal ImpairmentNCT07840313
Prophylactic Desmopressin Before Native Kidney Biopsy in Severe Renal Impairment
A study testing Desmopressin Acetate and NO DESMOPRESSIN in people with Severe Renal Impairment, run by Sindh Institute of Urology and Transplantation at 1 site in Pakistan.
Trial summary
This study evaluated whether giving desmopressin before a native kidney biopsy reduces bleeding complications in adults with severe renal impairment (eGFR <30 mL/min/1.73 m²). Patients undergoing kidney biopsy were enrolled sequentially into two groups: a non-desmopressin group and a desmopressin group. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Severe Renal Impairment
- What is being tested?
- Desmopressin Acetate and NO DESMOPRESSIN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2017to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:Adults aged 18 years or older who provided informed consent, had an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m², and underwent native kidney biopsy for a clinical indication, irrespective of dialysis status.
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Exclusion Criteria:Pregnant women, kidney transplant recipients, and patients with contraindications to kidney biopsy.
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Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sindh Institute of Urology and Transplantation (SIUT)
Karachi, Sindh, 74200
About this study
Official title: Prophylactic Desmopressin and Bleeding Outcomes After Native Kidney Biopsy in Patients With Severe Renal Impairment: A Prospective Sequential Cohort Study
This study evaluated whether giving desmopressin before a native kidney biopsy reduces bleeding complications in adults with severe renal impairment (eGFR <30 mL/min/1.73 m²). Patients undergoing kidney biopsy were enrolled sequentially into two groups: a non-desmopressin group and a desmopressin group. Patients were monitored for 24 hours after biopsy for bleeding complications, including perinephric hematoma, a decrease in hemoglobin, blood in the urine, need for blood transfusion, and other complications. The study also evaluated whether desmopressin was associated with adverse effects such as low blood sodium levels.
Read the detailed description
This prospective sequential cohort study evaluated the association between prophylactic intranasal desmopressin use and bleeding complications following native kidney biopsy in adults with severe renal impairment. The study was conducted at the Sindh Institute of Urology and Transplantation (SIUT), Karachi, from October 2024 to September 2025. Adults aged 18 years or older with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m² who underwent native kidney biopsy for clinical indications were consecutively enrolled. Patients were sequentially enrolled into a non-desmopressin cohort from October 2024 to March 2025 and a desmopressin cohort from April 2025 to September 2025. All patients underwent ultrasound-guided kidney biopsy and were monitored clinically and by ultrasonography for 24 hours after the procedure. The study evaluated post-biopsy bleeding complications and safety outcomes, including perinephric hematoma, hemoglobin decline, gross hematuria, blood transfusion, invasive interventions, and changes in serum sodium.
- Conditions
- Severe Renal Impairment
- Being tested
- Desmopressin Acetate, NO DESMOPRESSIN
- Keywords
- DESMOPRESSIN, NATIVE KIDNEY BIOPSY, SEVERE RENAL IMPAIRMENT, CHRONIC KIDNEY DISEASE
- Medical subject headings
- Renal Insufficiency, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desmopressin AcetateDrug
Prophylactic intranasal desmopressin acetate administered before native kidney biopsy in adults with severe renal impairment (eGFR <30 mL/min/1.73 m²). Patients were monitored for 24 hours after biopsy for bleeding complications and safety outcomes.
NO DESMOPRESSINOther
| Study group | Role | What they receive |
|---|---|---|
| Non-Desmopressin Group | Active comparator | Patients undergoing native kidney biopsy who did not receive prophylactic desmopressin. Patients were monitored for 24 hours after biopsy for bleeding complications and other safety outcomes. Receives: Other: NO DESMOPRESSIN |
| Desmopressin Group | Experimental | Patients undergoing native kidney biopsy who received prophylactic intranasal desmopressin before the biopsy. Patients were monitored for 24 hours after biopsy for bleeding complications and other safety outcomes. Receives: Drug: Desmopressin Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall bleeding complications after native kidney biopsy
Occurrence of any post-biopsy bleeding complication, including clinically relevant perinephric hematoma, hemoglobin decline ≥2 g/dL, persistent or clinically significant gross hematuria, or other clinically significant bleeding complications.
Measured: Within 24 hours after kidney biopsy
Secondary outcomes (1)
Perinephric hematoma >5 cm, Hemoglobin decline ≥2 g/dL, Blood transfusion requirement, Hyponatremia
Assessment of post-biopsy bleeding and safety outcomes, including perinephric hematoma >5 cm, hemoglobin decline ≥2 g/dL, clinically significant gross hematuria, blood transfusion requirement, and other clinically significant post-biopsy complications.
Measured: Within 24 hours after kidney biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Aug 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Renal ImpairmentStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were enrolled sequentially into two cohorts: a non-desmopressin cohort from October 2024 to March 2025 and a desmopressin cohort from April 2025 to September 2025. The cohorts were compared with respect to post-biopsy bleeding and safety outcomes.
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sindh Institute of Urology and Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siddiq Kakar, Sindh Institute of Urology and Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840313
- Sponsor's protocol ID
- 487
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Desmopressin and Bleeding Outcomes After Native Kidney Biopsy in Patients With Severe Renal Impairment: A Prospective Sequential Cohort Study
- ClinicalTrials.gov ID
- NCT07840313
- Acronym / sponsor ID
- 487
- Conditions
- Severe Renal Impairment
- Keywords
- DESMOPRESSIN, NATIVE KIDNEY BIOPSY, SEVERE RENAL IMPAIRMENT, CHRONIC KIDNEY DISEASE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Sindh Institute of Urology and TransplantationUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 25 Sep 2026 (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.
This study evaluated whether giving desmopressin before a native kidney biopsy reduces bleeding complications in adults with severe renal impairment (eGFR <30 mL/min/1.73 m²). Patients undergoing kidney biopsy were enrolled sequentially into two groups: a non-desmopressin group and a desmopressin group. Patients were monitored for 24 hours after biopsy for bleeding complications, including perinephric hematoma, a decrease in hemoglobin, blood in the urine, need for blood transfusion, and other complications. The study also evaluated whether desmopressin was associated with adverse effects such as low blood sodium levels.
Detailed description
This prospective sequential cohort study evaluated the association between prophylactic intranasal desmopressin use and bleeding complications following native kidney biopsy in adults with severe renal impairment. The study was conducted at the Sindh Institute of Urology and Transplantation (SIUT), Karachi, from October 2024 to September 2025. Adults aged 18 years or older with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m² who underwent native kidney biopsy for clinical indications were consecutively enrolled. Patients were sequentially enrolled into a non-desmopressin cohort from October 2024 to March 2025 and a desmopressin cohort from April 2025 to September 2025. All patients underwent ultrasound-guided kidney biopsy and were monitored clinically and by ultrasonography for 24 hours after the procedure. The study evaluated post-biopsy bleeding complications and safety outcomes, including perinephric hematoma, hemoglobin decline, gross hematuria, blood transfusion, invasive interventions, and changes in serum sodium.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were enrolled sequentially into two cohorts: a non-desmopressin cohort from October 2024 to March 2025 and a desmopressin cohort from April 2025 to September 2025. The cohorts were compared with respect to post-biopsy bleeding and safety outcomes.
| Arm | Type | Receives |
|---|---|---|
| Non-Desmopressin Group | Active comparator | Other: NO DESMOPRESSINPatients undergoing native kidney biopsy who did not receive prophylactic desmopressin. Patients were monitored for 24 hours after biopsy for bleeding complications and other safety outcomes. |
| Desmopressin Group | Experimental | Drug: Desmopressin AcetatePatients undergoing native kidney biopsy who received prophylactic intranasal desmopressin before the biopsy. Patients were monitored for 24 hours after biopsy for bleeding complications and other safety outcomes. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Desmopressin AcetateProphylactic intranasal desmopressin acetate administered before native kidney biopsy in adults with severe renal impairment (eGFR <30 mL/min/1.73 m²). Patients were monitored for 24 hours after biopsy for bleeding complications and safety outcomes. | Drug | Desmopressin Group |
| NO DESMOPRESSIN | Other | Non-Desmopressin Group |
Primary outcome
Overall bleeding complications after native kidney biopsy
Time frame: Within 24 hours after kidney biopsy
Occurrence of any post-biopsy bleeding complication, including clinically relevant perinephric hematoma, hemoglobin decline ≥2 g/dL, persistent or clinically significant gross hematuria, or other clinically significant bleeding complications.
1 secondary outcome
Perinephric hematoma >5 cm, Hemoglobin decline ≥2 g/dL, Blood transfusion requirement, Hyponatremia
Time frame: Within 24 hours after kidney biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desmopressin Acetate and NO DESMOPRESSIN in people with Severe Renal Impairment, run by Sindh Institute of Urology and Transplantation at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 25 Sep 2026. 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 Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall bleeding complications after native kidney biopsy (time frame: Within 24 hours after kidney biopsy). 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 25 Sep 2026.