Working for a better survival of transplanted kidneys (from the left):
Two studies of the "Integrierten Forschungs- und Behandlungszentrum (IFB-Tx)" (integrated reaserch- and treatment-centre) are sponsored by the BMBF and the DFG. The "Bundesministerium für Bildung und Forschung (BMBF)" (federal ministry of education and research) and the "Deutsche Forschungsgemeinschaft (DGF)" (Geman reasearch community) sponsor, with about 1.8 Million Euros, two studies for longer survival of transplanted kidneys, lead by researchers at the "Medizinische Hochschule Hannover (MHH)" (medical school Hannover). These resources were granted in the context of the shared DFG-BMBF special program for clinical studies ("Klinische Studien"). The examinations concern a new drug for the increased survival of transplanted kidneys inside the recipients body and a new method for earlier detection of rejection of transplanted kidneys. Both studies are part of the BMBF sponsored IFB-Tx.
RIACT-Study: New drugs for kindey transplant patients?
If organ rejection is beginning in kindey tranplants, it is usually treated with cortisone. This treatment does not show sufficient effectiveness in some patients, which is why researchers in from 13 German centres are looking for further options in the RIACT-Study. The BMBF granted the researchers almost 1.3 Million Euros for this purpose. Dr. Lena Schiffer, Professor Dr. Wilfried Gwinner and Professor Dr. Mario Schiffer lead developement of the the study. They work at the clinic for kindey- and hypertension-diseases at the medical school in Hannover (MHH), whose director Professor Dr. Hermann Haller is the head of clinical trials. The trial begins in july and lasts for three and a half years. Until now it has been assumed that mainly T-lymphocytes are responsible for rejection, which is the reason that currently practiced treatment is directed against these cells. But new research results indicate that about 30% of patients with rejection show other white blood cells in the tissue of the kidney: Certain B-lymphocytes. "It is possible that the current rejection therapy works suboptimally because it has no effect on these cells. Because of this we now examine in this trial the effect of a drug that affects B-cells. This drug is rituximab, which is already approved for treatmant of cancer and severe rheumatism", says professor Haller.
The reaserchers investigate whether the additional application of rituximab in addition to cortisone therapy, better protects kidney funtion that cortisone therapy alone. 180 kidney transplant patiets, who have been diagnosed with acute rejection, are meant to be included in the trial. Half of them gets cortisone and rituximab the others only cortisone. The "central" question is whether kidney function improves. This can be judged with a simple blood test a year later. Additional tissue samples are taked a year after treatment from the transplanted kidney to compere the extend of scarring. "Less scarring in patients treated with rituximab would hint at an advantage of that therapy", explains assistant doctor Dr. Schiffer.
New diagnostic method: Urine test and mass-spectrometry instead of biopsy?
Fot the second trial on the rejection of transplanted kidneys, which is also lead by the MHH, the DFG pledged financial support of about half a million Euros.
Researches of at least eight big research transplantation centres examine, since july 2011 for three years, whether it is possible to detect kidney rejection early on with a urine test. The researchers will analyse all proteins in the urien (the proteome) with mass-spectometry. 600 patients, whose kidney has to be biopsied because of an acute deterioration of kindey function, are meant to participate in the study. If a urine test should be of the same value for diagnosing rejection it would have strong advantaged over a biopsy: "A urine test does not carry the risks of a biopsy - for example bleeding. The test can also be done more frequently than a biopsy", says trail leader professor Dr. Wilfried Gwinner, Oberarzt (attending/senior staff member) of the MHH-clinic for kidney- and hypertension-diseases.
Bothe trials were developed as part of the IFB-Tx. This MHH-network that was founded in 2008 employs workers from 30 departments for integrative work. Foundational research and patiend-related clinical trials stimulate each other for the development of newer, better therapies. The institute for biometrics under the leadership of Professor Dr. Armin Koch also contributed to the trial designs. Other institutions contibute to the trial implementation: The Hannover Clinical Trial Center (HCTC) and the institute for pathology are involved in both trials. To the RIACT-trial also contributed: The institute for clinical pharmacology, the clinic for hematology and oncoloby and stem cell tranplantation, the pharmacy.
Further infromation is availible from Professor Dr. Hermann Haller, Telefone (0049-511) 532-6320, haller.hermann@mh-hannover.deSource: MHH
