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

NCT03676361 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: STUDY00142279
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Damage

Keywords

Kidney Damage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sensitivity of serum creatinine when compared to change in tubular function, pre and post nephrectomy as measured in MG/DL.

  6 months

• Sensitivity of urine albumin excretion when compared to change in tubular function, pre and post nephrectomy as measured in MCG/ML.

  6 months

• Sensitivity of eGFR when compared to change in tubular function, pre and post nephrectomy as measured in mL/min.

  6 months

Study Arms (1)

Desmopressin

EXPERIMENTAL

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

Drug: Desmopressin

Interventions

Desmopressin 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.

Desmopressin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Interventions

Deamino Arginine Vasopressin

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Pooja Budhiraja, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 18, 2018
• Study Start: August 29, 2018
• Primary Completion: April 26, 2019
• Study Completion: April 26, 2019
• Last Updated: May 20, 2019

Record last verified: 2019-05

Locations

US (1)