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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
IGA Nephropathy Drug: Budesonide Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study
Study Start Date : October 2005
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Budesonide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
The patient is his own control. Endpoint variables are measured before, during and after treatment.
Drug: Budesonide
8 mg PL-56 once daily for six months
Other Name: Nefecon, PL-56 (topical acting, anti-inflammatory agent)

Primary Outcome Measures :
  1. U-albumin [ Time Frame: 6(treatment)+3(follow-up) months ]

Secondary Outcome Measures :
  1. GFR and safety [ Time Frame: 6(treatment) + 3(follow-up) months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00767221

Linköping University Hospital
Linköping, Sweden
Huddinge University Hospital
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden
Sponsors and Collaborators
Calliditas Therapeutics AB
Archimedes Development Ltd
Principal Investigator: Bengt Fellström, MD, PhD Uppsala University Hospital, Dept. of Medicine

Responsible Party: Johan Häggblad, Pharmalink AB Identifier: NCT00767221     History of Changes
Other Study ID Numbers: U-03-003
First Posted: October 7, 2008    Key Record Dates
Last Update Posted: April 21, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists