Everolimus on CKD Progression in ADPKD Patients | NCT01009957

Studies
Everolimus on CKD Progression in ADPKD Patients

NCT01009957

Sponsor

A. Manzoni Hospital

Status

Terminated

Last Update Posted

Jun 23, 2015Estimated

Enrollment

71Actual

Phase

Phase 2Phase 3

Conditions

Polycystic Kidney Diseases

Interventions

Everolimus

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

After primary completition date, experimental drug was no longer available

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jan 2014Actual

Completion Date

Jun 2015Actual

First Submitted Date

Nov 6, 2009

First Submission Date that Met QC Criteria

Nov 6, 2009

First Posted Date

Nov 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2015

Last Update Posted Date

Jun 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study will evaluate whether the administration of everolimus (1.5 mg/day) can slow down the progression of CKD in ADPKD patients.

Detailed Description

Considering the inhibitor activity of Everolimus on mTOR, our hypothesis is to evaluate its possible utility on the progression of CKD in ADPKD patients by reducing the rate of increase of renal cysts.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Everolimus	Experimental	Everolimus + standard therapy for CKD	Drug: Everolimus
Control	No Intervention	Standard therapy for CKD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Everolimus	Drug	0.75 mg x 2 / day	Everolimus	mTOR inhibitors

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of GFR (according to MDRD formula) during a two-year follow up		Two year-followup

Secondary Outcomes

Measure	Description	Time Frame
reduction of creatinine clearance and GFR (according to Cockcroft-Gault formula) during a two-year follow up		Two year-followup
changes in kidney size and renal and liver cysts dimensions evaluated by NMR at basal and at the end of the study		Two year-followup

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects over 18 years of both genders
Clinical diagnosis of autosomal dominant polycystic kidney disease (ADPKD)
GFR, according to MDRD formula, between 30 and 90 ml/min/1.73 mq
Previous follow up of two years, with a creatinine evaluation at least once a year
GFR reduction of at least 2.5 ml/min/year (according to MDRD formula)

Exclusion Criteria:

Pregnancy, lactating, males and females without adequate contraception
Leucopenia (< 3,000 leucocytes/mm3) or thrombocytopenia (< 100,000 platelets/mm3)
Dyslipidemia (cholesterol or triglycerides > 260 mg/dl with treatment)
Urinary tract infection
Patients who cannot undergoing NMR

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francesco Locatelli, MD	Nephrology and Dialysis Department - A. Manzoni Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
A.O. Spedali Civili Di Brescia		Brescia			Italy
Alessandro Manzoni Hospital, Nephrology and Dialysis Department

Condition Browse Module

MeSH Terms

ID	Term
D007690	Polycystic Kidney Diseases
D016891	Polycystic Kidney, Autosomal Dominant

Ancestor Terms

ID	Term
D052177	Kidney Diseases, Cystic
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068338	Everolimus
D000091203	MTOR Inhibitors

Ancestor Terms

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D047428

Browse Leaves

Not provided

Browse Branches

Not provided