NCT00748072

Brief Summary

The investigators evaluated the effect of pre-biopsy treatment with 1-deamino-8-D-arginine (DDAVP) on the incidence of post-biopsy bleeding complications. This is a IV phase single centre, double blind, randomized controlled study in patients, with acute and chronic nephropathy, undergoing ultrasound-guided percutaneous renal biopsy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

January 13, 2015

Completed
Last Updated

January 13, 2015

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

September 5, 2008

Results QC Date

December 30, 2014

Last Update Submit

December 30, 2014

Conditions

Kidney Failure

Keywords

Vasopressinbleedingbiopsyultrasonography

Outcome Measures

Primary Outcomes (1)

  • The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications.

    Immediately post-biopsy and 24 hours post-biopsy.

Study Arms (2)

Saline solution

PLACEBO COMPARATOR

patients treated with 1 ml of s.c. saline solution

Drug: saline solution

DDAVP

EXPERIMENTAL

treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy

Drug: DDAVP

Interventions

DDAVPDRUG

0.3 mcg/kg subcutaneous

Also known as: vasopressin
DDAVP
saline solutionDRUG

saline solution 1 ml subcutaneous

Also known as: placebo
Saline solution

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females \> 16 and \< 80 years of age.
  • Blood pressure \< 140/90 mmHg.
  • Serum creatinine ≤ 1.5 mg/dl and/or creatinine clearance ≥ 60 ml/min.
  • Bleeding time, prothrombin time, partial thromboplastin time, platelets and fibrinogen in the normal range.

You may not qualify if:

  • Biopsy of transplant kidney
  • Poorly controlled hypertension
  • Single kidney
  • Renal cancer
  • Hydro/pyonephrosis
  • Renal size significantly reduced
  • Severe obesity
  • Coagulation disorder
  • Serum creatinine \> 1.5 mg/dl and/or creatinine clearance \< 60 ml/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center and Atelier for Epidemiological Studies, University of Bari

Bari, Bari, 70124, Italy

Location

Related Publications (1)

  • Manno C, Bonifati C, Torres DD, Campobasso N, Schena FP. Desmopressin acetate in percutaneous ultrasound-guided kidney biopsy: a randomized controlled trial. Am J Kidney Dis. 2011 Jun;57(6):850-5. doi: 10.1053/j.ajkd.2010.12.019. Epub 2011 Feb 26.

    PMID: 21354681DERIVED

MeSH Terms

Conditions

Renal InsufficiencyDiabetes InsipidusHemorrhage

Interventions

Deamino Arginine VasopressinVasopressinsSaline Solution

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arginine VasopressinPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Limitations and Caveats

A possible limitation of the study is the single-center design of the study, which could reduce the generalizability of our results and their external validity.

Results Point of Contact

Title
Dr. Carlo Manno
Organization
University of Bari
c.manno@nephro.uniba.it
390805478878

Study Officials

  • Carlo Manno, MD

    University of Bari

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Chair of Nephrology, Unit of Nephrology, University of Bari, Bari, Italy

Study Record Dates

First Submitted

September 5, 2008

First Posted

September 8, 2008

Study Start

August 1, 2008

Primary Completion

August 1, 2009

Study Completion

December 1, 2009

Last Updated

January 13, 2015

Results First Posted

January 13, 2015

Record last verified: 2014-12

Locations

IT(1)