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

This study has been completed.
Sponsor:
Collaborator:
Archimedes Development Ltd
Information provided by:
Pharmalink AB
ClinicalTrials.gov Identifier:
NCT00767221
First received: October 5, 2008
Last updated: April 20, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
IGA Nephropathy
Drug: Budesonide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study

Resource links provided by NLM:


Further study details as provided by Pharmalink AB:

Primary Outcome Measures:
  • U-albumin [ Time Frame: 6(treatment)+3(follow-up) months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GFR and safety [ Time Frame: 6(treatment) + 3(follow-up) months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: October 2005
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767221

Locations
Sweden
Linköping University Hospital
Linköping, Sweden
Huddinge University Hospital
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden
Sponsors and Collaborators
Pharmalink AB
Archimedes Development Ltd
Investigators
Principal Investigator: Bengt Fellström, MD, PhD Uppsala University Hospital, Dept. of Medicine
  More Information

No publications provided

Responsible Party: Johan Häggblad, Pharmalink AB
ClinicalTrials.gov Identifier: NCT00767221     History of Changes
Other Study ID Numbers: U-03-003
Study First Received: October 5, 2008
Last Updated: April 20, 2009
Health Authority: Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on August 26, 2014