Oral Treatment With PL-56 in Patients With IgA Nephropath... | NCT00767221

Studies
Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study

NCT00767221

Sponsor

Calliditas Therapeutics AB

Status

Completed

Last Update Posted

Apr 21, 2009Estimated

Enrollment

20Estimated

Phase

Phase 2

Conditions

IGA Nephropathy

Interventions

Budesonide

Countries

Sweden

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

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Nov 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Oct 5, 2008

First Submission Date that Met QC Criteria

Oct 5, 2008

First Posted Date

Oct 7, 2008Estimated

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

Apr 20, 2009

Last Update Posted Date

Apr 21, 2009Estimated

Name	Class
Archimedes Development Ltd	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
A	Experimental	The patient is his own control. Endpoint variables are measured before, during and after treatment.	Drug: Budesonide

Name	Type	Description	Arm Group Labels	Other Names
Budesonide	Drug	8 mg PL-56 once daily for six months	A	Nefecon, PL-56 (topical acting, anti-inflammatory agent)

Measure	Description	Time Frame
U-albumin		6(treatment)+3(follow-up) months

Measure	Description	Time Frame
GFR and safety		6(treatment) + 3(follow-up) months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent
Female or male patient > 18 years
Biopsy-verified IgA nephropathy
Proteinuria: U-albumin >500 mg/24 h
S-creatinine < 200 umol/L
A minimum of four available sample results (U-albumin and S-creatinine) prior to inclusion in the study.

Exclusion Criteria:

Severe gastrointestinal disorders which may impair drug effect, or other conditions which could modify the effect of the trial drug as judged by the investigator
Consumption of an investigational drug within 30 days prior to enrolment
Unacceptable blood pressure (treated or untreated), defined as a systolic value >150 mm Hg and/or diastolic >90 mm Hg
Hyperlipidaemia defined as unacceptable levels of lipids according to the discretion of the Investigator
Patients in whom an ACE inhibitor was introduced/changed during the last three months prior to enrolment
Patients treated with immuno-suppressive drugs
Patients unable to take oral medication
Severe liver disease (defined as ASAT and/or ALAT and/or gamma-GT above twice the normal value).
Uncontrolled (treated or untreated) congestive heart failure as judged by the Investigator
Patients with diabetes
Patients with current malignancy or history of malignancy during the last three years
History or presence of psychological or psychiatric illness which may interfere with the patient´s ability to adhere to the protocol
Alcohol or drug abuse (present)
Patients unwilling to meet the requirements of the protocol
Other medical or social reasons for exclusion at the discretion of the Investigator
Use of drugs inhibiting the cytochrome P-450 enzyme CYP3A4 (including grape fruit juice)
Kidney transplanted patients
For women only: pregnant or breast feeding; unwilling to use adequate contraception during the study (only women of childbearing potential)

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

Facility	Status	City	State	ZIP	Country	Contacts
Linköping University Hospital		Linköping			Sweden
Huddinge University Hospital

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases

ID	Term
D019819	Budesonide
D000893	Anti-Inflammatory Agents

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473