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

IGA Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00767221
• Other study ID #: U-03-003
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2008
• Last updated: April 20, 2009
• Start date: October 2005
• Est. completion date: November 2008

Study information

• Verified date: April 2009
• Source: Pharmalink AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IGA Nephropathy
• Kidney Diseases

Intervention

Drug:
• Budesonide
8 mg PL-56 once daily for six months

Locations

Country	Name	City	State
Sweden	Linköping University Hospital	Linköping
Sweden	Huddinge University Hospital	Stockholm
Sweden	Uppsala University Hospital	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Pharmalink AB	Archimedes Development Ltd

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	U-albumin		6(treatment)+3(follow-up) months	No
Secondary	GFR and safety		6(treatment) + 3(follow-up) months	Yes