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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00767221
Recruitment Status : Completed
First Posted : October 7, 2008
Last Update Posted : April 21, 2009
Archimedes Development Ltd
Information provided by:
Calliditas Therapeutics AB

October 5, 2008
October 7, 2008
April 21, 2009
October 2005
November 2008   (Final data collection date for primary outcome measure)
U-albumin [ Time Frame: 6(treatment)+3(follow-up) months ]
Same as current
Complete list of historical versions of study NCT00767221 on Archive Site
GFR and safety [ Time Frame: 6(treatment) + 3(follow-up) months ]
Same as current
Not Provided
Not Provided
Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study
Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study
The study will investigate the effect of PL-56 on albumin leakage and renal function (glomerular filtration rate) in patients with IgA nephropathy. It will also assess the safety of treatment with PL-56.
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
IGA Nephropathy
Drug: Budesonide
8 mg PL-56 once daily for six months
Other Name: Nefecon, PL-56 (topical acting, anti-inflammatory agent)
Experimental: A
The patient is his own control. Endpoint variables are measured before, during and after treatment.
Intervention: Drug: Budesonide
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2008
November 2008   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Johan Häggblad, Pharmalink AB
Calliditas Therapeutics AB
Archimedes Development Ltd
Principal Investigator: Bengt Fellström, MD, PhD Uppsala University Hospital, Dept. of Medicine
Calliditas Therapeutics AB
April 2009

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