Status:
COMPLETED
Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study
Lead Sponsor:
Calliditas Therapeutics AB
Collaborating Sponsors:
Archimedes Development Ltd
Conditions:
IGA Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00767221
Start Date
October 1 2005
End Date
November 1 2008
Last Update
April 21 2009
Active Locations (3)
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1
Linköping University Hospital
Linköping, Sweden
2
Huddinge University Hospital
Stockholm, Sweden
3
Uppsala University Hospital
Uppsala, Sweden