Dynamic Measurement of Renal Functional Reserve as a Predictor of Long-Term Renal Function

NCT03442647 | Unknown

• 1 other identifier: 2017-01839
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The number of people with kidney disease is constantly rising and renal failure represents one of the major health care burdens globally. An accurate measurement of kidney function is urgently needed to better understand and treat loss of renal function. Kidneys have an intrinsic reserve capacity to respond to a higher work load by increasing filtration in their nephrons. The number of nephrons and their reserve capacity define how well kidneys can adapt to an increased demand and disease. The degree of renal reserve capacity becomes particularly important when the number of functioning nephrons is significantly reduced either due to surgical removal of one kidney as in living kidney donation or in tumor nephrectomy or due to progressive injury as in autosomal dominant polycystic kidney disease (ADPKD). A reduced functional reserve likely reflects an impaired adaptive capacity and increased risk of accelerated loss of function in the remaining single kidney or in kidneys exposed to a disease. Despite the importance of accurately measuring baseline and reserve capacity renal function, due to the time- and laborintensive procedure, in clinical routine this testing is rarely done. Investigators aim to measure renal functional reserve (RFR) and loss of function in patients undergoing nephrectomy (living kidney donors and renal tumor patients) as well as in patients with ADPKD. The results should provide evidence whether renal functional reserve indeed predicts adaptive capacity and functional loss after removal of a healthy kidney (living donors), of a tumor kidney (cancer patients) or in progressive kidney disorders (ADPKD patients). Investigators are confident that the proposed project will enhance the understanding of progressive kidney disease and with this improve donor safety, planning of tumor nephrectomy, and prediction of renal functional loss as well as provide a strong argument that dynamic renal function testing, i.e. accurate measurement of baseline and reserve capacity, is necessary in certain disease entities.

Conditions

Adult Polycystic Kidney Disease; Kidney Neoplasms; Kidney Dysfunction

Outcome Measures

Primary Outcomes (1)

• RFR predicts renal functional decline

  Sinistrin levels in plasma before and after oral protein load. Participants with impaired RFR are expected to have higher sinitrin levels in plasma.

  up to 8 months

Study Arms (3)

Living donors

ACTIVE COMPARATOR

sinistrin clearance dynamic measurement

Diagnostic Test: sinistrin clearance dynamic measurement

ADPKD patients

ACTIVE COMPARATOR

sinistrin clearance dynamic measurement

Diagnostic Test: sinistrin clearance dynamic measurement

Patients with primary renal tumor

ACTIVE COMPARATOR

sinistrin clearance dynamic measurement

Diagnostic Test: sinistrin clearance dynamic measurement

Interventions

sinistrin clearance dynamic measurement DIAGNOSTIC_TEST

sinistrin clearance measurements will be performed before and 90 min after oral protein load

ADPKD patients; Living donors; Patients with primary renal tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential living kidney donor
• Patients with diagnosed ADPKD
• Patients with primary kidney tumor requiring nephrectomy
• Female and male patients over 18 years of age

You may not qualify if:

• Bilateral kidney tumor
• Kidney metastases of a tumor of other origin
• Renal failure that requires dialysis
• Pregnant patient
• Incomplete medical records
• Patients with diabetes mellitus
• Patients who cannot tolerate iv fluids
• Hypersensitivity to the active substance (sinistrin) or to any of the excipients

Sponsors & Collaborators

• Thomas Mueller: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Thomas F Mueller, Prof.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas F Mueller, Prof.

CONTACT

+41 44 255 33 84; thomas.mueller@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 22, 2018
• Study Start: June 1, 2018
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2019
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

CH (1)