Efficacy, Safety and Tolerability of Everolimus in Preventing End-Stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease - Full Text View

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00414440

Purpose

This study will assess whether everolimus (RAD001) is effective in preventing cyst and kidney expansion as well as worsening of renal function in patients with ADPKD and whether the application of 5 mg/day everolimus as monotherapy is safe and well tolerated.

Condition	Intervention	Phase
Autosomal Dominant Polycystic Kidney Disease	Drug: RAD001 placebo Drug: RAD001	Phase III

Genetics Home Reference related topics: polycystic kidney disease

MedlinePlus related topics: MRI Scans

Drug Information available for: Everolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study on the Efficacy, Safety and Tolerability of Everolimus in Preventing End-Stage Renal Disease (ESRD) in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Further study details as provided by Novartis:

Primary Outcome Measures:

Mean total kidney volume assessed by magnetic resonance imaging at 3 timepoints from the first day to the last day on study medication

Secondary Outcome Measures:

changes in mean cyst and parenchyma volumes assessed by magnetic resonance imaging between the first and last day on study medication.
changes in renal function assessed by urinalysis at 8 timepoints from the first day to last day on study medication.
incidence of newly developing end-stage renal disease (ESRD) assessed by number of patients who require renal replacement therapy during the conduct of the trial
safety and tolerability of the study drug assessed by monitoring and recording of adverse events, serious adverse events, and all infections
changes in blood pressure between the first and last day on study medication assessed by blood pressure measurements at 10 timepoints

Estimated Enrollment:	400
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2009

Arms	Assigned Interventions
1: Experimental	Drug: RAD001 experimental
2: Placebo Comparator	Drug: RAD001 placebo placebo comparator

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria

Clinical diagnosis of autosomal dominant polycystic kidney disease ADPKD
Chronic kidney disease (CKD) stage II / III
Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at baseline, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility

Exclusion Criteria

ADPKD patients with normal renal function
ADPKD patients with CKD stage IV
Patients with a history of subarachnoid bleeding
Patients with a history of severe infections
Patients with life-threatening urinary tract or cyst infection in the past
Patients who have received any investigational drug within four weeks prior to baseline
Patients who have been treated with any non-protocol immunosuppressive drug or treatment within one month prior to baseline

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414440

Contacts

Contact: Novarts Pharmaceuticals

41 61 324 1111

Locations

Germany
Novartis Investigative Site	Recruiting
Freiburg, Germany
Contact: Novartis Pharmaceuticals 41 61 324 1111

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CRAD001ADE12
Study First Received:	December 20, 2006
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00414440
Health Authority:	Germany: Bundesinstitut für Arzneimittel und Medizinproduke

Keywords provided by Novartis:

end-stage renal disease, ESRD, autosomal dominant polycystic kidney disease, ADPKD, everolimus

Study placed in the following topic categories:

Everolimus
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Polycystic Kidney, Autosomal Dominant

Kidney Diseases, Cystic
Polycystic Kidney Diseases
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009