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Trial · Interventional

WithdrawnPhase 4Registry data

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

NCTNCT03676361 (opens ClinicalTrials.gov in a new tab)Other idSTUDY00142279
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Withdrawn
Phase
Phase 4
Enrollment
0 participants (actual)
Sponsor
University of Kansas Medical Center · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
29 Aug 2018
Primary completion
26 Apr 2019
Completion
26 Apr 2019
First posted
18 Sept 2018
Last update posted
20 May 2019
Conditions
Kidney Damage

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201820192020
  1. Ph 4

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

    NCT03676361

    29 Aug 2018 to 26 Apr 2019

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DesmopressinDrug

Arms1

  • Experimental

    Desmopressin

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  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.

    Time frame · 6 months

    Registry description

    Tubular function is measured as maximal urine concentrating capacity reached after water deprivation and administration of desmopressin.

Secondary outcomes(3)

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

    Time frame · 6 months

    Registry description

    To test correlations between biomarkers all variables will be log-normalized and Pearson's regression analysis will be used

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

    Time frame · 6 months

    Registry description

    To test correlations between biomarkers all variables will be log-normalized and Pearson's regression analysis will be used

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

    Time frame · 6 months

    Registry description

    To test correlations between biomarkers all variables will be log-normalized and Pearson's regression analysis will be used

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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