Clinical trial NCT03676361: To Evaluate the Renal Tubular Function Pre and Post Nephrectomy in Living Donors
Official title: To Evaluate the Renal Tubular Function Pre and Post Nephrectomy in Living Donors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Kidney Damage
Keywords: Kidney Damage
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage change in tubular function (urine osmolality measured in MOSMOL/K) pre and post nephrectomy as assessed through water deprivation and administration of desmopressin.
timeFrame: 6 months
Secondary outcomes:
measure: Sensitivity of serum creatinine when compared to change in tubular function, pre and post nephrectomy as measured in MG/DL.
timeFrame: 6 months
measure: Sensitivity of urine albumin excretion when compared to change in tubular function, pre and post nephrectomy as measured in MCG/ML.
timeFrame: 6 months
measure: Sensitivity of eGFR when compared to change in tubular function, pre and post nephrectomy as measured in mL/min.
timeFrame: 6 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Pooja Budhiraja, MD
role: PRINCIPAL_INVESTIGATOR
References: