ASCEND- D Trial: Testing a novel medication to help treat anaemia in patients with chronic renal disease

The ASCEND D Trial has recently completed enrolment at Middlemore Hospital, Auckland, New Zealand. This clinical trial was a Phase III trial that consisted of patients who had anaemia (low red blood cell count) associated with chronic kidney disease (CKD) and were receiving dialysis. Due to the high incidence of diabetes in the Counties Manukau district there are many patients with chronic kidney disease.

The clinical trial medication being tested was an oral tablet given to participants to safely boost the production of erythropoietin (EPO), a hormone that increases red cell production. Normally the kidneys produce EPO but in CKD due to the damage to the patients’ kidneys the amount of EPO produced is insufficient.

Red blood cells carry oxygenated blood throughout the body. Anaemia or a low numbers of red blood cells leads to anaemia resulting in decreased daily functional ability and quality of life.

The clinical trial looked at the use of a novel oral medication to stimulate EPO production in diseased kidneys compared to the currently used injections in a population of high unmet need.

Clinical Trial Outcomes:

Target Recruitment: 30 patients.

Patients recruited: 30 patients.

Middlemore Clinical Trials was one of the highest recruiting sites in the Asia Pacific Region

 

Reasons for success in this trial:

• A very engaged, proactive enthusiastic Principal Investigator (PI) with the support of engaged sub- investigators and the Renal department at Middlemore Hospital. There was also excellent co-ordination and collaboration between the multiple dialysis units.

• Increased health literacy among the participants leading to very high patient compliance

• Very effective team approach to Clinical trials and Research

   

Due to the success of the clinical trial an independent overseas monitor was asked to review the trial. The Monitors comments were:

• A very collegial MMCT study team - with excellent interpersonal relationships

• The medical oversight provided by the PI and sub PIs thought the study was excellent

• Communication within the MMCT study team was of a very high standard

• Very well developed internal processes – SOP’s

• The informed consent process was excellent, given the degree of health literacy and renal cognitive impairment

• MMCT facilities are impressive and the having dedicated research nurse not a hybrid model of clinical and research nurse mix was praised

• A central repository of calibration certificates of equipment, temperature logs –very impressive

• The MMCT Monitors handbook and the relationship with the monitor involving a partnership model is rarely seen in other sites

• Timely entry of eCRF entry and the correlation with the primary source again was very impressive

   

  Enrolment has closed for the ASCEND D trial. For information on the ASCEND trial, contact Chris.Hood@middlemore.nz

   

  For information about participating in renal trials or to refer a participant, contact Participants@mmclintrials.nz or call the participant line at 59758 (free call 0800 27 27 84)

   

  For information on doing research (as an investigator) with Middlemore Clinical Trials, contact John.Baker@mmclintrials.nz or check Paanui