DRUG
Desmopressin
Subjects will complete a water deprivation test using desmopressin to aid in the determination of maximum tubular concentration capacity before and six months after uni-nephrectomy.
To Evaluate the Renal Tubular Function Pre and Post Nephrectomy in Living Donors
Status
Withdrawn
Phase
Phase 4
Enrollment
0
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The overall goals of this study are to demonstrate the change in renal tubular function in living donors pre and post nephrectomy at 6 months.
Full detailed description
The physiologic sequelae of living kidney donation are still poorly understood. Uni-nephrectomy from donation results in decreased number of glomeruli and research has shown that there is glomerular hyperfiltration and glomerular hypertrophy. Uni-nephrectomy also results in a decreased number of tubules, but there is not much data about possible tubular injury post donation and its long term effects on donors. Our overall hypothesis is that post uni-nephrectomy tubular function, measured by maximum urine concentration capacity, will be decreased and may be a more sensitive marker of kidney damage than standard tests, such as urine albumin, serum creatinine, estimated glomerular filtration rate (eGFR), or measured urine creatinine clearance (CrCl). The goal of this study is to evaluate the effect of uni-nephrectomy on renal tubular function and its potential in being an early and more sensitive marker in kidney injury when compared to standard tests.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Sep 18, 2018
Study start
Aug 29, 2018
Primary completion
Apr 26, 2019
Study completion
Apr 26, 2019
Results posted
Not reported
Registry updated
May 20, 2019
Outcomes
What the study measures.
Primary outcomes
Percentage change in tubular function (urine osmolality measured in MOSMOL/K) pre and post nephrectomy as assessed through water deprivation and administration of desmopressin.
Time frame · 6 months
Tubular function is measured as maximal urine concentrating capacity reached after water deprivation and administration of desmopressin.
Secondary outcomes
Sensitivity of serum creatinine when compared to change in tubular function, pre and post nephrectomy as measured in MG/DL.
Time frame · 6 months
To test correlations between biomarkers all variables will be log-normalized and Pearson's regression analysis will be used
Sensitivity of urine albumin excretion when compared to change in tubular function, pre and post nephrectomy as measured in MCG/ML.
Time frame · 6 months
To test correlations between biomarkers all variables will be log-normalized and Pearson's regression analysis will be used
Sensitivity of eGFR when compared to change in tubular function, pre and post nephrectomy as measured in mL/min.
Time frame · 6 months
To test correlations between biomarkers all variables will be log-normalized and Pearson's regression analysis will be used
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- Yes
Inclusion Criteria: * Adult ≥18 years of age, who has been evaluated and approved as a potential living donor by the multi-disciplinary committee. All donors undergo a standard medical, social, and psychological pre- donation assessment * Only patients who are able to sign their own consent form may be included in this study. * Subjects must be able and willing, in the investigator's opinion, to complete all study requirements. Exclusion Criteria: * Subjects denied for donation for any medical, social or surgical reason to be living donor. * Patients who are contraindicated or relatively contraindicated for DDAVP: a. patients with von Willebrand disease; b. Patients with habitual or psychogenic polydipsia; c. Patients with coronary artery insufficiency and/or hypertensive cardiovascular disease; d. Patients with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, heart failure, and renal disorders; e. Patients predisposed to thrombus formation
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
University of Kansas Medical Center
Kansas City, Kansas, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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