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

Kidney Damage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03676361
• Other study ID #: STUDY00142279
• Status: Withdrawn
• Phase: Phase 4
• Start date: August 29, 2018
• Est. completion date: April 26, 2019

Study information

• Verified date: May 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 26, 2019
• Est. primary completion date: April 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Damage

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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