To Evaluate the Renal Tubular Function Pre and Post Nephrectomy in Living Donors

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.

Study Overview

• Status: Withdrawn
• Conditions: Kidney Damage
• Intervention / Treatment: Drug: Desmopressin

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University Of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Desmopressin; All ten subjects will be evaluated pre and post nephrectomy at 6 months.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in tubular function (urine osmolality measured in MOSMOL/K) pre and post nephrectomy as assessed through water deprivation and administration of desmopressin.	Tubular function is measured as maximal urine concentrating capacity reached after water deprivation and administration of desmopressin.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of serum creatinine when compared to change in tubular function, pre and post nephrectomy as measured in MG/DL.	To test correlations between biomarkers all variables will be log-normalized and Pearson's regression analysis will be used	6 months
Sensitivity of urine albumin excretion when compared to change in tubular function, pre and post nephrectomy as measured in MCG/ML.	To test correlations between biomarkers all variables will be log-normalized and Pearson's regression analysis will be used	6 months
Sensitivity of eGFR when compared to change in tubular function, pre and post nephrectomy as measured in mL/min.	To test correlations between biomarkers all variables will be log-normalized and Pearson's regression analysis will be used	6 months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Pooja Budhiraja, MD, University Of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 29, 2018
• Primary Completion (ACTUAL): April 26, 2019
• Study Completion (ACTUAL): April 26, 2019

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (ACTUAL): September 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Kidney Damage
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Antidiuretic Agents; Deamino Arginine Vasopressin
• Other Study ID Numbers: STUDY00142279

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No