An Open-Label Phase II Study in anti-GBM disease (Goodpasture’s disease) with Adverse Renal Prognosis to Evaluate the Efficacy and Safety of IdeS --GOOD-IDES - GOOD-IDES

inköping University0 个研究点目标入组 15 人开始时间: 2018年4月12日最近更新: 2020年9月7日

适应症

试验速览

暂无简介。

•1. Anti-GBM antibodies detected by Enzyme-Linked Immunosorbent Assay (ELISA) above a level that is considered toxic by the investigator. Patients double-positive for anti-GBM and ANCA may be entered in the trial, but only if their level of anti-GBM antibodies fulfil the criteria above.
•2. eGFR < 15 ml/min/1.73 m2 (by MDRD equation) or if the patient is non-responsive to standard treatment, and has lost >15 ml/min/1.73 m2 after start of treatment.
•3. Haematuria on dipstick and/or urinary sediment.
•4. Male or female patients aged at least 18 years; Female patients of childbearing potential may participate if highly effective contraception is used during the study.
•5. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol; and
•6. Judged to be otherwise healthy by the Investigator, based on medical history, physical examination, and clinical laboratory assessments. Patients with clinical laboratory values that are outside of normal limits (other than those specified in the Exclusion Criteria) and/or with other abnormal clinical findings that are judged by the Investigator not to be of clinical significance, may be entered into the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 8
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 7

•1. Anuria for more than 48 hours (less than 200 ml)
•2. Dialysis dependency for more than 5 days (maximum 3 sessions before signing informed consent)
•3. Moderate to severe pulmonary haemorrhage as defined in the protocol
•4. Pregnant
•5. Symptomatic congestive heart failure (NYHA class 2-4) requiring prescription medication or clinically evident peripheral edema of cardiac origin
•6. Myocardial infarction, unstable angina or stroke within 3 months prior to screening
•7. Ongoing bacterial infection requiring antibiotic therapy or viral infection with Hepatitis B, C or HIV; or active tuberculosis as indicated by chest x-ray.
•8. Patients should not have received investigational drugs within 30 days prior to screening or within 4 half-lives (whichever is longer); and
•9. History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation.

发起方

inköping University