Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00414440
First received: December 20, 2006
Last updated: March 6, 2014
Last verified: March 2014

December 20, 2006
March 6, 2014
December 2006
October 2013   (final data collection date for primary outcome measure)
Mean total kidney volume assessed by magnetic resonance imaging at 3 timepoints from the first day to the last day on study medication
Same as current
Complete list of historical versions of study NCT00414440 on ClinicalTrials.gov Archive Site
  • 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
  • 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 aderse 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
Not Provided
Not Provided
 
Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease
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)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Autosomal Dominant Polycystic Kidney Disease
  • Drug: RAD001 placebo
    placebo comparator
  • Drug: RAD001
    experimental
    Other Name: certican
  • Experimental: 1
    Intervention: Drug: RAD001
  • Placebo Comparator: 2
    Intervention: Drug: RAD001 placebo
Walz G, Budde K, Mannaa M, Nürnberger J, Wanner C, Sommerer C, Kunzendorf U, Banas B, Hörl WH, Obermüller N, Arns W, Pavenstädt H, Gaedeke J, Büchert M, May C, Gschaidmeier H, Kramer S, Eckardt KU. Everolimus in patients with autosomal dominant polycystic kidney disease. N Engl J Med. 2010 Aug 26;363(9):830-40. doi: 10.1056/NEJMoa1003491. Epub 2010 Jun 26. Erratum in: N Engl J Med. 2010 Nov 11;363(20):1977. N Engl J Med. 2010 Sep 16;363(12):1190.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
431
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria

  1. Clinical diagnosis of autosomal dominant polycystic kidney disease ADPKD
  2. Chronic kidney disease (CKD) stage II / III
  3. 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

  1. ADPKD patients with normal renal function
  2. ADPKD patients with CKD stage IV
  3. Patients with a history of subarachnoid bleeding
  4. Patients with a history of severe infections
  5. Patients with life-threatening urinary tract or cyst infection in the past
  6. Patients who have received any investigational drug within four weeks prior to baseline
  7. 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

Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Germany
 
NCT00414440
CRAD001ADE12, 2006-001485-16
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP