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

NCT ID: NCT03676361

Last Updated: 2019-05-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-29
• Study Completion Date: 2019-04-26

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.

Conditions

Kidney Damage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Desmopressin

All ten subjects will be evaluated pre and post nephrectomy at 6 months.

Group Type: EXPERIMENTAL

Desmopressin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Pooja Budhiraja, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pooja Budhiraja, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

STUDY00142279

Identifier Type: -

Identifier Source: org_study_id