www.ukhd.de
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- +49 6221 9112 0
- info@nierenzentrum-heidelberg.com
- Nierenzentrum Heidelberg am Universitätsklinikum Heidelberg, INF 162 69120 Heidelberg
Study Center
We conduct research to improve diagnostics and treatment
Clinical studies are a prerequisite for the development of new diagnostic methods and treatment options. The results of clinical research have contributed to the fact that many diseases can now be diagnosed at an early stage and optimal therapy can be applied.
The Heidelberg Kidney Center - Nephrology Section of the Medical University Hospital - has many years of extensive experience in planning and conducting clinical trials on a national and international level.
The Nephrology Study Center is ISO 9001:2008 certified.
Studies are planned and conducted professionally to a high quality standard in accordance with regulatory requirements and the German Medicines Act.
We are currently conducting clinical trials for the following indications:
- Kidney transplantation
- Immunosuppression
- Therapeutic drug monitoring (drug monitoring via blood levels)
- Living kidney donation
- Chronic renal insufficiency
- Familial cystic kidneys
- Glomerulonephritis
- Autoimmune diseases (e.g. vasculitis, lupus erythematosus)
- Diabetic nephropathy
- Renal artery stenosis
Depending on requirements, we can expand the indications in the fields of nephrology, immunology and hypertensiology.
Study team leader
Prof. Dr. med. Claudia Sommerer, M.Sc.
Specialist in internal medicine, specializing in nephrology Master of Science Clinical Research Management, senior physician and head of the Clinical Study Center.
Since the beginning of her medical career, Prof. Dr. Sommerer has supervised a large number of clinical studies and drug trials as an investigator and study director. She is actively involved in the preparation of study plans for mono- and multicenter studies in the field of nephrology.
Senior study assistant
Ute von der Emde
Registered nurse, further training as ward manager, focus on clinical trials and clinical monitoring, head study assistant at the Clinical Study Center.
After completing her training, Ms. von der Emde initially worked in various departments at the Philipps University of Marburg as a nurse and ward manager. She has been working as a study assistant at the renal center since 2006. Her main responsibilities include the care of patients in transplantation and cystic kidney studies as well as therapeutic drug monitoring.
A clinical trial is conducted with patients or healthy volunteers to test the efficacy and safety of drugs, certain forms of treatment or medical interventions.
The aim of clinical trials is to answer scientific questions and improve medical treatment and diagnostics for future patients.
Every planned study must first be reviewed by the responsible ethics committee, which is made up of doctors, scientists, lawyers and theologians.
The conduct of clinical trials on patients is carefully reviewed and monitored both nationally and internationally. In recent years, a standard has been developed at European level under the collective term "Good Clinical Practice" (GCP), which contains essential criteria and principles for the conduct and evaluation of studies. The GCP rules ensure patient protection and the quality of the results obtained.
Initially, as part of preclinical research, potential new drugs are tested on animals for their effectiveness and safety. This generally takes place in special research laboratories, which are often affiliated with pharmaceutical companies. Once a substance has successfully passed this phase, the first clinical trials begin. Initially, data on efficacy and pharmacology is collected on healthy volunteers. Depending on the progress of development, the studies are divided into so-called clinical phases.
Phase 1 - Pharmacokinetics, pharmacodynamics, tolerability and safety of the drug
Phase 2 - review of the therapy concept (phase 2a) and determination of the appropriate therapy dose (phase 2b)
Phase 3 - significant proof of efficacy and marketing authorization; after marketing authorization, ongoing studies become phase 3b studies
Phase 4 - Approved drugs are used in approved indications. Phase 4 trials are used to identify rare side effects in large patient populations
Clinical trials are necessary for the progress and improvement of patient care. The safety, efficacy and quality of new diagnostic methods or drugs are carried out and analyzed in a controlled manner on patients as part of a clinical trial. New medicines may only be approved for general use after a sufficient number of positive study results have been obtained.
If you participate in a study as a patient, you will receive one of the best treatment options currently known. You will be monitored particularly closely and receive regular follow-up examinations. In addition, you will contribute to the development of promising new treatment concepts that may later be available to you and many other patients.
To ensure that study results are not subjectively influenced, neither the doctor nor the patient knows which treatment the patient is receiving. In emergencies, however, the treatment information can be disclosed (unblinding).
In a placebo-controlled study, one group of patients receives the active ingredient (the substance being tested), while the other receives a placebo that does not contain any active ingredient. In contrast, there are "actively controlled" studies in which one group of patients receives the active substance to be tested and the other an established medication. Effect and tolerability are compared with each other.
Randomization is used to ensure the comparability of groups treated with different procedures. Randomization means a random allocation of the study participants to the treatment groups.
Monocentric means that a study is conducted at a single institution (e.g. Heidelberg Kidney Center). The results must be evaluated with regard to the specifics of the respective department.
Multicenter means that a study is conducted in a large number of institutions (e.g. clinics). In this way, local factors influencing the study results can be minimized.
A study participant has the right to be informed in detail about everything related to the study. The data will be treated confidentially and evaluated "pseudonymized" (without connection to the name). Anyone who no longer wishes to participate in a study can withdraw their consent at any time without any disadvantages.
Participation in a study is confirmed by signing a declaration of consent. A study participant must attend the scheduled examination appointments (visits) at the study center. Current changes in health status (acute illness, hospitalization, taking new medication) should be reported by the study participant to the study center as soon as possible.
